Veregen is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

The safety and effectiveness of Veregen have not been established for treatment beyond 16-weeks or for multiple treatment courses.

The safety and effectiveness of Veregen in immunosuppressed patients have not been established.

Veregen is to be applied three times per day to all external genital and perianal warts.

Apply about an 0.5 cm strand of the Veregen to each wart using the finger(s), dabbing it on to ensure complete coverage and leaving a thin layer of the ointment on the warts. Patients should wash their hands before and after application of Veregen.

It is not necessary to wash off the ointment from the treated area prior to the next application.

Veregen® is not for ophthalmic, oral, intravaginal, or intra-anal use.

Treatment with Veregen should be continued until complete clearance of all warts, however no longer than 16 weeks.

Local skin reactions (e.g. erythema) at the treatment site are frequent. Nevertheless, treatment should be continued when the severity of the local skin reaction is acceptable.

{ "type": "", "children": [], "text": "" }

None

{ "type": "p", "children": [], "text": "None" }

Veregen has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions.

{ "type": "p", "children": [], "text": "Veregen has not been evaluated for the treatment of urethral, intra-vaginal, cervical, rectal, or intra-anal human papilloma viral disease and should not be used for the treatment of these conditions." }

Use of Veregen on open wounds should be avoided.

{ "type": "p", "children": [], "text": "Use of Veregen on open wounds should be avoided." }

Patients should be advised to avoid exposure of the genital and perianal area to sun/UV-light as Veregen has not been tested under these circumstances.

{ "type": "p", "children": [], "text": "Patients should be advised to avoid exposure of the genital and perianal area to sun/UV-light as Veregen has not been tested under these circumstances." }

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

{ "type": "p", "children": [], "text": "Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice." }

In Phase 3 clinical trials, a total of 397 subjects received Veregen three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks.

{ "type": "p", "children": [], "text": "In Phase 3 clinical trials, a total of 397 subjects received Veregen three times per day topical application for the treatment of external genital and perianal warts for up to 16 weeks." }

Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women.

{ "type": "p", "children": [], "text": "Serious local adverse events of pain and inflammation were reported in two subjects (0.5%), both women. " }

In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.

{ "type": "p", "children": [], "text": "In clinical trials, the incidence of patients with local adverse events leading to discontinuation or dose interruption (reduction) was 5% (19/397). These included the following events: application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers." }

Local and regional reactions (including adenopathy) occurring at >1% in the treated groups are presented in Table 1.

{ "type": "p", "children": [], "text": "Local and regional reactions (including adenopathy) occurring at >1% in the treated groups are presented in Table 1." }

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 1: Local and Regional Adverse Reactions During Treatment (% Subjects)</span> </caption> <col width="33%"/> <col width="33%"/> <col width="33%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Toprule" valign="top"> <p class="First">Veregen<span class="Sup">®</span> <br/> <span class="Italics">(N = 397)</span> </p> </td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Vehicle<br/> <span class="Italics">(N = 207)</span> </p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Erythema</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">70</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">32</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Pruritus</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">69</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">45</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Burning</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">67</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">31</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Pain/discomfort</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">56</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">14</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Erosion/Ulceration</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">49</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">10</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Edema</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">45</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">11</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Induration</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">35</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">11</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Rash vesicular</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">20</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">6</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Regional Lymphadenitis</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">3</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">1</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Desquamation</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">5</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">&lt;1</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Discharge</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">3</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">&lt;1</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Bleeding</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">2</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">&lt;1</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Reaction</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">2</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Scar</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">1</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">Irritation</p> </td><td align="center" class="Lrule" valign="top"> <p class="First">1</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule" valign="top"> <p class="First">Rash</p> </td><td align="center" class="Botrule Lrule" valign="top"> <p class="First">1</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span>Table 1: Local and Regional Adverse Reactions During Treatment (% Subjects)</span>\n</caption>\n<col width=\"33%\"/>\n<col width=\"33%\"/>\n<col width=\"33%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Toprule\" valign=\"top\"></td><td align=\"center\" class=\"Botrule Lrule Toprule\" valign=\"top\">\n<p class=\"First\">Veregen<span class=\"Sup\">®</span>\n<br/>\n<span class=\"Italics\">(N = 397)</span>\n</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Vehicle<br/>\n<span class=\"Italics\">(N = 207)</span>\n</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Erythema</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">70</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">32</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Pruritus</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">69</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">45</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Burning</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">67</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">31</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Pain/discomfort</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">56</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">14</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Erosion/Ulceration</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">49</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">10</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Edema</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">45</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">11</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Induration</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">35</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">11</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Rash vesicular</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">20</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">6</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Regional Lymphadenitis</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">3</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">1</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Desquamation</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">5</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">&lt;1</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Discharge</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">3</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">&lt;1</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Bleeding</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">2</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">&lt;1</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Reaction</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">2</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">0</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Scar</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">1</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">0</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">Irritation</p>\n</td><td align=\"center\" class=\"Lrule\" valign=\"top\">\n<p class=\"First\">1</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">0</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">Rash</p>\n</td><td align=\"center\" class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">1</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">0</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

A total of 266/397 (67%) of subjects in the Veregen group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only.

{ "type": "p", "children": [], "text": "A total of 266/397 (67%) of subjects in the Veregen group had either a moderate or a severe reaction that was considered probably related to the drug, of which 120 (30%) subjects had a severe reaction. Severe reactions occurred in 37% (71/192) of women and in 24% (49/205) of men. The percentage of subjects with at least one severe, related adverse event was 26% (86/328) for subjects with genital warts only, 42% (19/45) in subjects with both genital and perianal warts and 48% (11/23) of subjects with perianal warts only. " }

Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen and in 1% (1/99) in vehicle.

{ "type": "p", "children": [], "text": "Phimosis occurred in 3% of uncircumcised male subjects (5/174) treated with Veregen and in 1% (1/99) in vehicle." }

The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment.

{ "type": "p", "children": [], "text": "The maximum mean severity of erythema, erosion, edema, and induration was observed by week 2 of treatment." }

Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia.

{ "type": "p", "children": [], "text": "Less common local adverse events included urethritis, perianal infection, pigmentation changes, dryness, eczema, hyperesthesia, necrosis, papules, and discoloration. Other less common adverse events included cervical dysplasia, pelvic pain, cutaneous facial rash, and staphylococcemia." }

In a dermal sensitization study of Veregen in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions.

{ "type": "p", "children": [], "text": "In a dermal sensitization study of Veregen in healthy volunteers, hypersensitivity (type IV) was observed in 5 out of 209 subjects (2.4%) under occlusive conditions." }

Risk Summary

There are no available data on Veregen use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal reproduction studies, sinecatechins did not cause malformations, but did affect the developing fetus in the presence of maternal toxicity when given to pregnant rabbits and rats by intravaginal or systemic routes of administration during the period of organogenesis (see Data). The available data do not allow the calculation of relevant comparisons between the systemic exposure of sinecatechins observed in the animal studies to the systemic exposure that would be expected in humans after topical use of Veregen.

Data

Embryo-fetal development studies were conducted in rats and rabbits using intravaginal and systemic routes of administration, respectively. Oral administration of sinecatechins during the period of organogenesis (gestational Days 6 to 15 in rats or 6 to 18 in rabbits) did not cause treatment-related malformations or effects on embryo-fetal development at doses of up to 1,000 mg/kg/day.

In the presence of maternal toxicity (characterized by marked local irritation at the administration sites and decreased body weight and food consumption) in pregnant female rabbits, subcutaneous doses of 12 and 36 mg/kg/day of sinecatechins during the period of organogenesis (gestational Days 6 to 19) resulted in corresponding influences on fetal development including reduced fetal body weights and delays in skeletal ossification. No treatment-related effects on embryo-fetal development were noted at 4 mg/kg/day. No malformations were noted at any of the doses evaluated in this study.

A combined fertility and embryo-fetal development study using daily vaginal administration of Veregen to rats from Day 4 before mating and throughout mating until Day 17 of gestation did not show treatment-related effects on fertility, malformations, or embryo-fetal development at doses up to 0.15 mL/rat/day. This dose corresponds to approximately 150 mg/rat/day.

A pre- and post-natal development study was conducted in rats using vaginal administration of Veregen at doses of 0.05, 0.10 and 0.15 mL/rat/day from Day 6 of gestation through parturition and lactation. The high and intermediate dose levels of 0.15 and 0.10 mL/rat/day resulted in an increased mortality of the F0 dams, associated with indications of parturition complications. The high dose level of 0.15 mL/rat/day also resulted in an increased incidence of stillbirths. There were no other treatment-related effects on pre- and post-natal development, growth, reproduction and fertility at any dose tested.

Risk Summary

There are no data on the presence of sinecatechins in human or animal milk, the effects on the breastfed child, or the effects on milk production. After topical application, Veregen concentrations in plasma are low and therefore concentrations in human breast milk are likely to be low [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Veregenand any potential adverse effects on the breast-fed child from Veregenor from the underlying maternal condition.

Safety and effectiveness in pediatric patients have not been established.

Seven patients (1.4%), older than 65 years of age were treated with Veregen in clinical studies. This, however, is an insufficient number of subjects to determine whether they respond differently from younger subjects.

Veregen (sinecatechins) Ointment, 15% is a botanical drug product for topical use. The drug substance in Veregen is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze, and is a mixture of catechins and other green tea components. Catechins constitute 85 to 95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg), and some additional minor catechin derivatives i.e. Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves.

{ "type": "p", "children": [], "text": "Veregen (sinecatechins) Ointment, 15% is a botanical drug product for topical use. The drug substance in Veregen is sinecatechins, which is a partially purified fraction of the water extract of green tea leaves from Camellia sinensis (L.) O Kuntze, and is a mixture of catechins and other green tea components. Catechins constitute 85 to 95% (by weight) of the total drug substance which includes more than 55% of Epigallocatechin gallate (EGCg), other catechin derivatives such as Epicatechin (EC), Epigallocatechin (EGC), Epicatechin gallate (ECg), and some additional minor catechin derivatives i.e. Gallocatechin gallate (GCg), Gallocatechin (GC), Catechin gallate (Cg), and Catechin (C). In addition to the known catechin components, it also contains gallic acid, caffeine, and theobromine which together constitute about 2.5% of the drug substance. The remaining amount of the drug substance contains undefined botanical constituents derived from green tea leaves." }

The structural formulae of catechins are shown below.

{ "type": "p", "children": [], "text": "The structural formulae of catechins are shown below." }

General Structure of Catechins

{ "type": "p", "children": [], "text": "\nGeneral Structure of Catechins\n" }

Each gram of the ointment contains 150 mg of sinecatechins in a water free ointment base consisting of isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.

{ "type": "p", "children": [], "text": "Each gram of the ointment contains 150 mg of sinecatechins in a water free ointment base consisting of isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol." }

The mode of action of Veregen involved in the clearance of genital and perianal warts is unknown. In vitro, sinecatechins had anti-oxidative activity; the clinical significance of this finding is unknown.

The pharmacodynamics of Veregen is unknown.

In an oral (gavage) carcinogenicity study, sinecatechins was administered daily for 26 weeks to p53 transgenic mice at doses up to 500 mg/kg/day. Treatment with sinecatechins was not associated with an increased incidence of either neoplastic or non-neoplastic lesions in the organs and tissues examined. Veregen has not been evaluated in a dermal carcinogenicity study.

Sinecatechins was negative in the Ames test, in vivo rat micronucleus assay, UDS test, and transgenic mouse mutation assay, but positive in the mouse lymphoma mutation assay.

Daily vaginal administration of Veregen to rats from Day 4 before mating and throughout mating until Day 17 of gestation did not cause adverse effects on mating performance and fertility at doses up to 0.15 mL/rat/day.

Two randomized, double-blind, vehicle-controlled trials were performed to investigate the safety and efficacy of Veregen in the treatment of immunocompetent subjects 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment).

{ "type": "p", "children": [], "text": "Two randomized, double-blind, vehicle-controlled trials were performed to investigate the safety and efficacy of Veregen in the treatment of immunocompetent subjects 18 years of age and older with external genital and perianal warts. The subjects applied the ointment 3 times daily for up to 16 weeks or until complete clearance of all warts (baseline and new warts occurring during treatment)." }

Over both trials the median baseline wart area was 51 mm2 (range 12 to 585 mm2), and the median baseline number of warts was 6 (range 2 to 30).

{ "type": "p", "children": [], "text": "Over both trials the median baseline wart area was 51 mm2 (range 12 to 585 mm2), and the median baseline number of warts was 6 (range 2 to 30)." }

The primary efficacy outcome measure was the response rate defined as the proportion of subjects with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 2 and 3 for all randomized subjects dispensed medication.

{ "type": "p", "children": [], "text": "The primary efficacy outcome measure was the response rate defined as the proportion of subjects with complete clinical (visual) clearance of all external genital and perianal warts (baseline and new) by week 16, presented in Tables 2 and 3 for all randomized subjects dispensed medication." }

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 2: Efficacy by Region</span> </caption> <col width="50%"/> <col width="50%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Complete Clearance</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First"> <span class="Bold">All Countries</span> <br/> <span class="Bold"> (includes the United States)</span> </p> </td><td class="Lrule Rrule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">    Veregen<span class="Sup">®</span> 15% (<span class="Italics">N</span> = 397)</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">213 (53.6%)</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="top"> <p class="First">    Vehicle (<span class="Italics">N</span> = 207)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">73 (35.3%)</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First"> <span class="Bold">United States</span> </p> </td><td class="Lrule Rrule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">    Veregen<span class="Sup">®</span> 15% (<span class="Italics">N</span> = 21)</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">5 (23.8%)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule" valign="top"> <p class="First">    Vehicle (<span class="Italics">N</span> = 9)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">0 (0.0%)</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span>Table 2: Efficacy by Region</span>\n</caption>\n<col width=\"50%\"/>\n<col width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Toprule\" valign=\"top\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Complete Clearance</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">All Countries</span>\n<br/>\n<span class=\"Bold\"> (includes the United States)</span>\n</p>\n</td><td class=\"Lrule Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">    Veregen<span class=\"Sup\">®</span> 15% (<span class=\"Italics\">N</span> = 397)</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">213 (53.6%)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">    Vehicle (<span class=\"Italics\">N</span> = 207)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">73 (35.3%)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">United States</span>\n</p>\n</td><td class=\"Lrule Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">    Veregen<span class=\"Sup\">®</span> 15% (<span class=\"Italics\">N</span> = 21)</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">5 (23.8%)</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">    Vehicle (<span class=\"Italics\">N</span> = 9)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">0 (0.0%)</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

<div class="scrollingtable"><table width="100%"> <caption> <span>Table 3: Efficacy by Gender</span> </caption> <col width="50%"/> <col width="50%"/> <tbody class="Headless"> <tr class="First"> <td class="Botrule Lrule Toprule" valign="top"></td><td align="center" class="Botrule Lrule Rrule Toprule" valign="top"> <p class="First">Complete Clearance</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First"> <span class="Bold">Males</span> </p> </td><td class="Lrule Rrule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">    Veregen<span class="Sup">®</span> 15% (<span class="Italics">N</span> = 205)</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">97 (47.3%)</p> </td> </tr> <tr> <td class="Botrule Lrule" valign="top"> <p class="First">    Vehicle (<span class="Italics">N</span> = 118)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">34 (28.8%)</p> </td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First"> <span class="Bold">Females</span> </p> </td><td class="Lrule Rrule" valign="top"></td> </tr> <tr> <td class="Lrule" valign="top"> <p class="First">    Veregen<span class="Sup">®</span> 15% (<span class="Italics">N</span> = 192)</p> </td><td align="center" class="Lrule Rrule" valign="top"> <p class="First">116 (60.4%)</p> </td> </tr> <tr class="Last"> <td class="Botrule Lrule" valign="top"> <p class="First">    Vehicle (<span class="Italics">N</span> = 89)</p> </td><td align="center" class="Botrule Lrule Rrule" valign="top"> <p class="First">39 (43.8%)</p> </td> </tr> </tbody> </table></div>

{ "type": "table", "children": [], "text": "<div class=\"scrollingtable\"><table width=\"100%\">\n<caption>\n<span>Table 3: Efficacy by Gender</span>\n</caption>\n<col width=\"50%\"/>\n<col width=\"50%\"/>\n<tbody class=\"Headless\">\n<tr class=\"First\">\n<td class=\"Botrule Lrule Toprule\" valign=\"top\"></td><td align=\"center\" class=\"Botrule Lrule Rrule Toprule\" valign=\"top\">\n<p class=\"First\">Complete Clearance</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Males</span>\n</p>\n</td><td class=\"Lrule Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">    Veregen<span class=\"Sup\">®</span> 15% (<span class=\"Italics\">N</span> = 205)</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">97 (47.3%)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">    Vehicle (<span class=\"Italics\">N</span> = 118)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">34 (28.8%)</p>\n</td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">\n<span class=\"Bold\">Females</span>\n</p>\n</td><td class=\"Lrule Rrule\" valign=\"top\"></td>\n</tr>\n<tr>\n<td class=\"Lrule\" valign=\"top\">\n<p class=\"First\">    Veregen<span class=\"Sup\">®</span> 15% (<span class=\"Italics\">N</span> = 192)</p>\n</td><td align=\"center\" class=\"Lrule Rrule\" valign=\"top\">\n<p class=\"First\">116 (60.4%)</p>\n</td>\n</tr>\n<tr class=\"Last\">\n<td class=\"Botrule Lrule\" valign=\"top\">\n<p class=\"First\">    Vehicle (<span class=\"Italics\">N</span> = 89)</p>\n</td><td align=\"center\" class=\"Botrule Lrule Rrule\" valign=\"top\">\n<p class=\"First\">39 (43.8%)</p>\n</td>\n</tr>\n</tbody>\n</table></div>" }

Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials.

{ "type": "p", "children": [], "text": "Median time to complete wart clearance was 16 weeks and 10 weeks, respectively, in the two phase 3 clinical trials." }

The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen and 5.8% (4/69) for those treated with vehicle.

{ "type": "p", "children": [], "text": "The rate of recurrence of external genital and perianal warts 12 weeks after completion of treatment in subjects with complete clearance is 6.8% (14/206) for those treated with Veregen and 5.8% (4/69) for those treated with vehicle." }

Prior to dispensing to the patient, store refrigerated 2°C to 8°C (36°F to 46°F). After dispensing, store refrigerated or up to 25°C (77°F). Do not freeze.

See FDA-approved patient labeling (Patient Information)

{ "type": "p", "children": [], "text": "See FDA-approved patient labeling (Patient Information)" }

Patients using Veregen should receive the following information and instructions:

{ "type": "p", "children": [], "text": "Patients using Veregen should receive the following information and instructions:" }

{ "type": "", "children": [], "text": "" }

PATIENT INFORMATION

{ "type": "p", "children": [], "text": "\nPATIENT INFORMATION\n" }

Veregen® (sinecatechins) Ointment, 15%

{ "type": "p", "children": [], "text": "Veregen®\n(sinecatechins)\nOintment, 15%\n" }

Read this leaflet carefully before you start using Veregen Ointment and each time you refill your prescription. There may be new information. This information does not take the place of your doctor’s advice. If you have any questions about Veregen Ointment or your condition ask your doctor or pharmacist. Only your doctor can prescribe Veregen and determine if it is right for you.

{ "type": "p", "children": [], "text": "Read this leaflet carefully before you start using Veregen Ointment and each time you refill your prescription. There may be new information. This information does not take the place of your doctor’s advice. If you have any questions about Veregen Ointment or your condition ask your doctor or pharmacist. Only your doctor can prescribe Veregen and determine if it is right for you." }

What is Veregen Ointment?

{ "type": "p", "children": [], "text": "\nWhat is Veregen Ointment?\n" }

Veregen Ointment is a medicine for skin use only (topical) for the treatment of warts on the outside of the genitals and around the outside of the anus. It is not a treatment for warts in the vagina, cervix, or inside the anus. Your doctor may recommend examination and screening tests (such as a Pap smear) to evaluate these areas.

{ "type": "p", "children": [], "text": "Veregen Ointment is a medicine for skin use only (topical) for the treatment of warts on the outside of the genitals and around the outside of the anus. It is not a treatment for warts in the vagina, cervix, or inside the anus. Your doctor may recommend examination and screening tests (such as a Pap smear) to evaluate these areas." }

Who should not use Veregen Ointment?

{ "type": "p", "children": [], "text": "\nWho should not use Veregen Ointment?\n" }

Do not use Veregen Ointment if you are allergic to an ingredient in Veregen Ointment. The list of ingredients is at the end of this leaflet.

{ "type": "p", "children": [], "text": "Do not use Veregen Ointment if you are allergic to an ingredient in Veregen Ointment. The list of ingredients is at the end of this leaflet." }

What should I tell my doctor before using Veregen Ointment?

{ "type": "p", "children": [], "text": "\nWhat should I tell my doctor before using Veregen Ointment?\n" }

Tell your doctor about all your health conditions and all the medicines you take including prescription, over-the-counter medicine, vitamins, supplements, and herbals. Be sure to tell your doctor if you are:

{ "type": "p", "children": [], "text": "Tell your doctor about all your health conditions and all the medicines you take including prescription, over-the-counter medicine, vitamins, supplements, and herbals. Be sure to tell your doctor if you are:" }

{ "type": "", "children": [], "text": "" }

How should I use Veregen Ointment?

{ "type": "p", "children": [], "text": "\nHow should I use Veregen Ointment?\n" }

{ "type": "", "children": [], "text": "" }

What should I avoid while using Veregen Ointment?

{ "type": "p", "children": [], "text": "\nWhat should I avoid while using Veregen Ointment?\n" }

{ "type": "", "children": [], "text": "" }

What are the possible side effects of Veregen Ointment?

{ "type": "p", "children": [], "text": "\nWhat are the possible side effects of Veregen Ointment?\n" }

The most common side effects with Veregen Ointment are local skin and application site reactions including:

{ "type": "p", "children": [], "text": "The most common side effects with Veregen Ointment are local skin and application site reactions including:" }

{ "type": "", "children": [], "text": "" }

Many patients experience itching, reddening or swelling on or around the application site during the course of treatment. Some of these side effects could be a sign of an allergic reaction. If you experience open sores or other severe reactions at the locations you applied Veregen Ointment, stop treatment and call your doctor right away.

{ "type": "p", "children": [], "text": "Many patients experience itching, reddening or swelling on or around the application site during the course of treatment. Some of these side effects could be a sign of an allergic reaction. If you experience open sores or other severe reactions at the locations you applied Veregen Ointment, stop treatment and call your doctor right away." }

You may experience other side effects of Veregen Ointment which are not mentioned here. Ask your doctor or pharmacist for more information.

{ "type": "p", "children": [], "text": "You may experience other side effects of Veregen Ointment which are not mentioned here. Ask your doctor or pharmacist for more information." }

Patients should be aware that new warts may develop during treatment as Veregen Ointment is not a cure.

{ "type": "p", "children": [], "text": "Patients should be aware that new warts may develop during treatment as Veregen Ointment is not a cure." }

How should I store Veregen Ointment?

{ "type": "p", "children": [], "text": "\nHow should I store Veregen Ointment?\n" }

{ "type": "", "children": [], "text": "" }

Keep Veregen Ointment and all medicines out of the reach of children.

{ "type": "p", "children": [], "text": "\nKeep Veregen Ointment and all medicines out of the reach of children.\n" }

General advice about prescription medicines

{ "type": "p", "children": [], "text": "\nGeneral advice about prescription medicines\n" }

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Veregen Ointment for a condition for which it was not prescribed. Do not give Veregen Ointment to other people, even if they have the same symptoms you have. It may harm them.

{ "type": "p", "children": [], "text": "Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Veregen Ointment for a condition for which it was not prescribed. Do not give Veregen Ointment to other people, even if they have the same symptoms you have. It may harm them." }

Do not use Veregen Ointment after the expiration date on the tube.

{ "type": "p", "children": [], "text": "Do not use Veregen Ointment after the expiration date on the tube." }

This leaflet summarizes the most important information about Veregen Ointment. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Veregen Ointment that is written for the doctor.

{ "type": "p", "children": [], "text": "This leaflet summarizes the most important information about Veregen Ointment. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Veregen Ointment that is written for the doctor." }

For more information, go to www.anipharmaceuticals.com or call 1-800-308-6755.

{ "type": "p", "children": [], "text": "For more information, go to www.anipharmaceuticals.com or call 1-800-308-6755." }

What are the ingredients in Veregen Ointment?

{ "type": "p", "children": [], "text": "\nWhat are the ingredients in Veregen Ointment?\n" }

Active ingredient:

{ "type": "p", "children": [], "text": "\nActive ingredient:\n" }

A defined green tea extract named sinecatechins.

{ "type": "p", "children": [], "text": "A defined green tea extract named sinecatechins." }

Inactive ingredients:

{ "type": "p", "children": [], "text": "\nInactive ingredients:\n" }

Isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol.

{ "type": "p", "children": [], "text": "Isopropyl myristate, white petrolatum, cera alba (white wax), propylene glycol palmitostearate, and oleyl alcohol." }

Manufactured by:C.P.M. ContractPharma GmbH.Frühlingstrasse 7 D-83620Feldkirchen-Westerham, Germany

{ "type": "p", "children": [], "text": "Manufactured by:C.P.M. ContractPharma GmbH.Frühlingstrasse 7 D-83620Feldkirchen-Westerham, Germany" }

Distributed by:ANI Pharmaceuticals, Inc.Baudette, MN 56623

{ "type": "p", "children": [], "text": "Distributed by:ANI Pharmaceuticals, Inc.Baudette, MN 56623\n" }

U.S. Patent Nos. 5795911 and 5968973

{ "type": "p", "children": [], "text": "U.S. Patent Nos. 5795911 and 5968973" }

0-20720-00 Rev 01/22

{ "type": "p", "children": [], "text": "0-20720-00 Rev 01/22" }

This Patient Information has been approved by the U.S. Food and Drug Administration.

{ "type": "p", "children": [], "text": "This Patient Information has been approved by the U.S. Food and Drug Administration." }

VEREGEN® (sinecatechins) Ointment15 %For Topical Use Only30g

{ "type": "p", "children": [], "text": "\nVEREGEN®\n(sinecatechins) Ointment15 %For Topical Use Only30g \n" }