Acne Vulgaris

• FDA approval · 2026-08-21
  FDA Approved: ISOTRETINOIN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  Supplemental application approval for isotretinoin from Zydus Pharmaceuticals USA Inc. (ANDA).

• FDA approval · 2026-08-21
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approves a supplemental application for AMNESTEEM (isotretinoin) from Mylan Pharmaceuticals Inc., indicating a label or indication updat…

• FDA approval · 2026-08-07
  FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Original Application (ACTAVIS LABS UT INC)

  FDA approval information for an original application of a clindamycin phosphate and benzoyl peroxide combination product by Actavis Labs UT …

• FDA approval · 2026-03-25
  FDA Approved: TRETINOIN — Original Application (Encube Ethicals, Inc.)

  FDA approved Encube Ethicals, Inc.'s original application for a generic tretinoin product. The approval supports its use as a topical retino…

• FDA approval · 2026-03-10
  FDA Approved: ADAPALENE — Supplemental Application (Walgreens)

  FDA approved a supplemental application for Adapalene by Walgreens, approving an additional change to the approved generic product under AND…

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• EMA approval · 2026-02-10
  EMA Authorised: Winlevi (clascoterone) — Cassiopea S.p.A.

  The European Medicines Agency has authorized Winlevi (clascoterone) by Cassiopea S.p.A. for acne vulgaris.

• FDA approval · 2026-02-10
  FDA Approved: TRETINOIN — Original Application (Encube Ethicals, Inc.)

  FDA approves Encube Ethicals, Inc.'s original application for a generic tretinoin product (ANDA 217833). This marks the first generic versio…

• FDA approval · 2026-02-09
  FDA Approved: ISOTRETINOIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for isotretinoin from Amneal Pharmaceuticals NY LLC, enabling a generic version of the acne medicati…

• FDA approval · 2026-02-09
  FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)

  The FDA approved a supplemental application for isotretinoin from Mayne Pharma.

• FDA approval · 2026-02-09
  FDA Approved: ABSORICA LD — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for ABSORICA LD (isotretinoin) submitted by Sun Pharmaceutical Industries, expanding/altering th…

• FDA approval · 2026-02-09
  FDA Approved: ISOTRETINOIN — Supplemental Application (Upsher-Smith Laboratories, LLC)

  The FDA approved a supplemental application for isotretinoin from Upsher-Smith Laboratories, LLC, to modify/expand the existing labeling of …

• FDA approval · 2026-02-09
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for Claravis (isotretinoin) from Teva Pharmaceuticals USA, Inc.

• FDA approval · 2026-02-09
  FDA Approved: ISOTRETINOIN — Supplemental Application (Upsher-Smith Laboratories, LLC)

  FDA approved Upsher-Smith Laboratories' supplemental application for isotretinoin (ANDA213571).

• FDA approval · 2026-02-09
  FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for ABSORICA (isotretinoin) from Sun Pharmaceutical Industries, Inc., updating the labeling through …

• FDA approval · 2026-02-09
  FDA Approved: ISOTRETINOIN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for isotretinoin from Zydus Pharmaceuticals USA Inc.

• FDA approval · 2026-02-09
  FDA Approved: ISOTRETINOIN — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for isotretinoin from Actavis Pharma, Inc., authorizing changes to the approved product.

• FDA approval · 2026-02-09
  FDA Approved: ISOTRETINOIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approved a supplemental application for isotretinoin submitted by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2026-02-09
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for Claravis (isotretinoin) filed by Teva Pharmaceuticals USA, Inc., resulting in an approved mo…

• FDA approval · 2026-02-09
  FDA Approved: ZENATANE — Supplemental Application (BluePoint Laboratories)

  The FDA approved a supplemental application for ZENATANE (isotretinoin) submitted by BluePoint Laboratories, approving continued approval of…

• FDA approval · 2026-02-09
  FDA Approved: ISOTRETINOIN — Supplemental Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for isotretinoin submitted by Zydus Pharmaceuticals USA Inc. (ANDA 211568).

• FDA approval · 2026-02-09
  FDA Approved: ISOTRETINOIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for isotretinoin by Aurobindo Pharma Limited. This represents a routine approval for a generic isotr…

• FDA approval · 2025-10-07
  FDA Approved: ISOTRETINOIN — Original Application (Amneal Pharmaceuticals NY LLC)

  The FDA approved Amneal's original application for isotretinoin, a generic product, allowing its marketing in the United States. This approv…

• FDA approval · 2025-09-10
  FDA Approved: RETIN-A MICRO — Supplemental Application (Bausch Health US LLC)

  The FDA approved a supplemental application for RETIN-A MICRO (tretinoin) submitted by Bausch Health US LLC.

• FDA approval · 2025-08-18
  FDA Approved: ADAPALENE AND BENZOYL PEROXIDE — Supplemental Application (Alembic Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a topical combination product of adapalene and benzoyl peroxide by Alembic Pharmaceuticals f…

• FDA approval · 2025-08-14
  FDA Approved: TRETINOIN — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals' generic topical tretinoin through an Original Application (ANDA). The product is indicated for acne vu…