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

For the treatment of patients with external genital and perianal warts (EGW)...

VEREGEN® is the first botanical drug approved for prescription use in the United States1

In clinical studies:
  • 53.6% of VEREGEN® patients demonstrated complete clearance of EGW vs 35.3% for vehicle2
  • 93.2% of VEREGEN® patients with complete clearance of EGW experienced sustained clearance at 12 weeks posttreatment vs 94.2% for vehicle2

In two phase 3, randomized, double-blind, vehicle-controlled studies (United States and international) of immunocompetent male and female patients (N=604) aged 18 years and older who had EGW, VEREGEN®¬†or vehicle was applied 3 times daily until complete clinical (visual) clearance of all external genital or perianal warts (baseline and new) or up to 16 weeks. Those patients who experienced complete clearance of all warts were followed for a 12-week treatment-free period to assess sustained clearance.2

The most common adverse reactions were local skin and application site reactions including redness, itching, burning, pain, sores, swelling, hard spots, and rash with blisters.

  • The majority of adverse events were mild or moderate local application site reactions1-4
  • Only 2.3% of VEREGEN® patients discontinued treatment due to local adverse events1

VEREGEN® (sinecatechins) Ointment, 15% is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older.

Important Safety Information
Do not use VEREGEN® Ointment, 15% if you are allergic to any ingredient in this product. Do not use VEREGEN® Ointment, 15% for warts in the vagina, cervix, or inside the anus. Avoid contact with your eyes, nostrils and mouth while ointment is on your finger(s).

Avoid use of VEREGEN® on open wounds. Do not expose skin that has been treated with VEREGEN® to the sunlight, sunlamps or tanning beds. Tell your doctor if you are using any other type of skin product on the area to be treated. Avoid sexual contact (genital, anal or oral) when VEREGEN® Ointment, 15% is on your genital or perianal skin. If you do choose to have sexual contact, you must wash off the ointment carefully before having protected sexual contact as the ointment may weaken condoms and vaginal diaphragms.

Be sure to tell the doctor if you have a weak immune system, if you are pregnant or nursing a baby, or if you have used VEREGEN® before. Avoid using this product in patients younger than 18 years of age or for longer than 16 weeks. If your warts do not go away or come back after treatment contact your doctor.

The most common side effects with VEREGEN® Ointment, 15% are local skin and application site reactions including (incidence ≥ 20%): redness, itching, burning, pain, sores, swelling, hard spots, rash with blisters.

For more information, consult your healthcare professional.

Please see link to full Patient Information. VEREGEN® (sinecatechins) Ointment, 15% Patient Information

Please see link to full Prescribing Information. VEREGEN® (sinecatechins) Ointment, 15% Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA.

Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

The information on this website should not take the place of talking with your healthcare professional. If you need medical information, please talk to your healthcare professional.

References:
  1. Data on file, Fougera.
  2. VEREGEN® Ointment, 15% [Prescribing Information, 2018]. Melville. NY: PharmaDerm, part of Fougera Pharmaceuticals Inc.
  3. Stockfleth E, Beti H, Orasan R, et al. Topical Polyphenon® E in the treatment of external genital and perianal warts: a randomized controlled trial. Br J Dermatol. 2008;158(6):1329-1338.
  4. Tatti S, Swinehart JM, Thielert C, Tawfik H, Mescheder A, Beutner KR. Sinecatechins, a defined green tea extract, in the treatment of external anogenital warts: a randomized controlled trial. Obstet Gynecol. 2008;111(6):1371-1379.

KERYDIN® Indication and Important Safety Information

OXISTAT® Lotion Indication and Important Safety Information

VEREGEN® Indication and Important Safety Information

 

KERYDIN® Indication

KERYDIN® is a topical prescription medicine used to treat fungal infections of the toenails.

Important Safety Information

KERYDIN® (tavaborole) is for use on toenails only. Do not use KERYDIN® in your mouth, eyes, or vagina.

Tell your doctor about all of your medical conditions, including if you are pregnant or plan to become pregnant or are breastfeeding or plan to breastfeed. Talk to your healthcare provider about the best way to feed your baby during your treatment with KERYDIN®. It is not known if KERYDIN® can harm your unborn baby or if KERYDIN® passes into your breast milk. It is not known if KERYDIN® is safe and effective in children less than 6 years of age.

Use KERYDIN® exactly as your healthcare provider tells you to use it. Avoid getting KERYDIN® on skin that is not surrounding the treated toenail. KERYDIN® is flammable. Avoid heat and flame while applying KERYDIN® to your toenail.

KERYDIN® may cause irritation at or near the application site. The most common side effects of KERYDIN® include: skin peeling, ingrown toenail, redness, itching, and swelling. Tell your doctor if you have any side effect that bothers you or does not go away.

Please see link to Full Prescribing Information below.

KERYDIN® (tavaborole) Topical Solution, 5% Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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OXISTAT® Lotion Indication

OXISTAT® Lotion is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum.

Important Safety Information

Do not use OXISTAT® Lotion if you have hypersensitivity to any ingredient of this product.

Use the product only externally. OXISTAT® Lotion is not to be used in the eyes or vagina. Avoid contact with the eyes, nose, mouth, and other mucous membranes. Do not cover the treated area unless directed otherwise by your physician.

Use the medication for the full treatment time recommended by your physician, even though symptoms may have improved.

Inform the physician if the area of application shows signs of increased irritation, itching, burning, blistering, swelling, or oozing. In clinical studies with OXISTAT® Lotion, the most commonly reported side effects were burning and stinging; less commonly reported side effects were itching, scaling, tingling, pain, and blistering.

If you are pregnant or nursing a baby, consult with your physician prior to using this product. For more information, consult your physician.

Please see link to the Full Prescribing Information below.

OXISTAT® (oxiconazole nitrate) Lotion, 1% Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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VEREGEN® Indication

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

Important Safety Information

Do not use VEREGEN® Ointment, 15% if you are allergic to any ingredient in this product. Do not use VEREGEN® Ointment, 15% for warts in the vagina, cervix, or inside the anus. Avoid contact with your eyes, nostrils and mouth while ointment is on your finger(s).

Avoid use of VEREGEN® on open wounds. Do not expose skin that has been treated with VEREGEN® to the sunlight, sunlamps or tanning beds. Tell your doctor if you are using any other type of skin product on the area to be treated. Avoid sexual contact (genital, anal or oral) when VEREGEN® Ointment, 15% is on your genital or perianal skin. If you do choose to have sexual contact, you must wash off the ointment carefully before having protected sexual contact as the ointment may weaken condoms and vaginal diaphragms.

Be sure to tell the doctor if you have a weak immune system, if you are pregnant or nursing a baby, or if you have used VEREGEN® before. Avoid using this product in patients younger than 18 years of age or for longer than 16 weeks. If your warts do not go away or come back after treatment contact your doctor.

The most common side effects with VEREGEN® Ointment, 15% are local skin and application site reactions including (incidence ≥ 20%): redness, itching, burning, pain, sores, swelling, hard spots, rash with blisters.

For more information, consult your healthcare professional.

Please see link to full Patient Information. VEREGEN® (sinecatechins) Ointment, 15% Patient Information

Please see link to full Prescribing Information. VEREGEN® (sinecatechins) Ointment, 15% Full Prescribing Information

You are encouraged to report negative side effects of prescription drugs to the Food and Drug Administration (FDA).

Please visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

The information on this website should not take the place of talking with your healthcare professional. If you need medical information, please talk to your healthcare professional.

[back to top]