Genital Warts

• EMA approval · 2025-10-20
  EMA Authorised: Gardasil (human papillomavirus type 6 L1 protein;human papillomavirus type 11 L1 protein;human papillomavirus type 16 L1 protein;human papillomavirus type 18 L1 protein) — Merck Sharp & Dohme B.V.

  The EMA authorised Gardasil, a quadrivalent human papillomavirus vaccine, for prevention of HPV infections and related diseases such as cerv…

• EMA approval · 2025-10-09
  EMA Authorised: Gardasil 9 (human papillomavirus vaccine [types 6, 11, 16, 18, 31, 33, 45, 52, 58] (recombinant, adsorbed)) — Merck Sharp & Dohme B.V.

  The European Medicines Agency authorised Gardasil 9, a human papillomavirus vaccine. It is indicated for preventing HPV-related conditions i…

• EMA approval · 2025-07-18
  EMA Authorised: Aldara (imiquimod) — Viatris Healthcare Limited

  The European Medicines Agency authorised Aldara (imiquimod) for multiple indications under Viatris Healthcare Limited, including genital war…

• FDA approval · 2024-09-16
  FDA Approved: ZYCLARA — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for ZYCLARA (imiquimod) filed by Bausch Health US, LLC.

• FDA approval · 2023-11-22
  FDA Approved: PODOFILOX — Original Application (Padagis US LLC)

  FDA approved Padagis US LLC's Podofilox (podofilox) topical solution from an original ANDA for treating external genital warts caused by HPV…

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• FDA approval · 2021-01-26
  FDA Approved: IMIQUIMOD — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's Imiquimod as an Original Application (generic) product. It covers actinic keratosis, superficial basal…

• FDA approval · 2018-12-19
  FDA Approved: VEREGEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approves a supplemental application for Veregen (sinecatechins) from ANI Pharmaceuticals, Inc. This action represents a supplemental app…

• FDA approval · 2016-08-29
  FDA Approved: IMIQUIMOD — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Imiquimod submitted by Sun Pharmaceutical Industries. This action typically updates labeling…

• FDA approval · 2016-07-08
  FDA Approved: VEREGEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Veregen (sinecatechins) submitted by ANI Pharmaceuticals, Inc., indicating approval of the r…

• FDA approval · 2015-07-06
  FDA Approved: VEREGEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for VEREGEN (sinecatechins) submitted by ANI Pharmaceuticals, under NDA 021902.

• FDA approval · 2013-03-01
  FDA Approved: VEREGEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  FDA approved a supplemental application for Veregen (sinecatechin) submitted by ANI Pharmaceuticals, Inc.

• FDA approval · 2012-03-06
  FDA Approved: IMIQUIMOD — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's generic imiquimod 5% cream (ANDA 201994) as an original application, expanding access to the dermatology indications…

• FDA approval · 2008-09-18
  FDA Approved: VEREGEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for VEREGEN (sinecatechins) submitted by ANI Pharmaceuticals, Inc., for the product.

• FDA approval · 2007-12-19
  FDA Approved: VEREGEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for VEREGEN (sinecatechins) filed by ANI Pharmaceuticals, Inc.

• FDA approval · 2007-06-27
  FDA Approved: VEREGEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for Veregen (sinecatechin) submitted by ANI Pharmaceuticals.

• FDA approval · 2007-06-01
  FDA Approved: VEREGEN — Supplemental Application (ANI Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for VEREGEN (sinecatechins) by ANI Pharmaceuticals, signaling regulatory action on the product.

• FDA approval · 2006-10-31
  FDA Approved: VEREGEN — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved Veregen (sinecatechins) topical ointment under its original NDA for the treatment of external genital warts.