Acne Vulgaris

• FDA approval · 2024-04-29
  FDA Approved: TRETINOIN — Original Application (Alembic Pharmaceuticals Inc.)

  FDA lists Alembic Pharmaceuticals' generic tretinoin as approved in its Original Application (ANDA) for topical treatment of acne vulgaris.

• FDA approval · 2024-04-25
  FDA Approved: TRETINOIN — Original Application (Viona Pharmaceuticals Inc)

  FDA approved the original application for tretinoin from Viona Pharmaceuticals, authorizing a generic topical tretinoin product (for acne vu…

• FDA approval · 2024-04-11
  FDA Approved: ADAPALENE AND BENZOYL PEROXIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Adapalene and Benzoyl Peroxide from Sun Pharmaceutical Industries, expanding the approval of…

• FDA approval · 2024-03-14
  FDA Approved: DOXYCYCLINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approved Lupin Pharmaceuticals' original application for doxycycline, a generic antibiotic, expanding the availability of doxycycline pr…

• FDA approval · 2024-03-06
  FDA Approved: AZELAIC ACID — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for azelaic acid by Actavis Pharma, expanding/updating its labeling.

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• FDA approval · 2024-03-04
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2024-03-04
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2024-02-23
  FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Supplemental Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a supplemental application for Clindamycin Phosphate and Benzoyl Peroxide by Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2024-02-20
  FDA Approved: AZELEX — Supplemental Application (Almirall, LLC)

  FDA supplemental application for AZELEX (azelaic acid) submitted by Almirall, LLC.

• FDA approval · 2024-02-16
  FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)

  FDA approved a supplemental application for isotretinoin by Mayne Pharma, expanding the labeling for acne vulgaris.

• FDA approval · 2024-01-29
  FDA Approved: ISOTRETINOIN — Original Application (Aurobindo Pharma Limited)

  FDA approved Aurobindo Pharma Limited's original ANDA for isotretinoin (generic isotretinoin). Isotretinoin is used to treat severe acne vul…

• FDA approval · 2023-12-27
  FDA Approved: ADAPALENE — Supplemental Application (Mayne Pharma Commercial LLC.)

  FDA approved a supplemental application for adapalene submitted by Mayne Pharma Commercial LLC.

• FDA approval · 2023-12-14
  FDA Approved: ADAPALENE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for Adapalene by Sun Pharmaceutical Industries. The action concerns the product's approved indicatio…

• FDA approval · 2023-10-20
  FDA Approved: CABTREO — Original Application (Bausch Health US LLC)

  FDA approves CABTREO, a triple-combination topical acne medication containing clindamycin phosphate, benzoyl peroxide, and adapalene, for th…

• FDA approval · 2023-10-13
  FDA Approved: DAPSONE — Original Application (Encube Ethicals, Inc.)

  FDA approved Encube Ethicals, Inc.'s Original Application for DAPSONE GEL 5%, a topical dapsone formulation, as a generic product.

• FDA approval · 2023-09-07
  FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for Clindamycin Phosphate and Benzoyl Peroxide from Sun Pharmaceutical Industries.

• FDA approval · 2023-08-29
  FDA Approved: ISOTRETINOIN — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approves a generic isotretinoin product from Zydus Pharmaceuticals USA Inc. under an ANDA.

• FDA approval · 2023-08-22
  FDA Approved: TRETINOIN — Original Application (Encube Ethicals, Inc.)

  FDA approved the original application for tretinoin from Encube Ethicals, Inc., enabling a generic version of tretinoin.

• FDA approval · 2023-07-18
  FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ABSORICA (isotretinoin) from Sun Pharmaceutical Industries.

• FDA approval · 2023-07-18
  FDA Approved: ABSORICA LD — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for ABSORICA LD (isotretinoin) from Sun Pharmaceutical Industries, Inc.

• FDA approval · 2023-07-06
  FDA Approved: ADAPALENE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The U.S. FDA approved a supplemental application for Adapalene filed by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2023-06-23
  FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)

  FDA approved a supplemental application for isotretinoin from Mayne Pharma, extending or modifying the existing isotretinoin approval.

• FDA approval · 2023-06-06
  FDA Approved: DAPSONE — Original Application (Trupharma, LLC)

  FDA approved the generic DAPSONE GEL, 5% (dapsone gel) from Trupharma, LLC under an Original Application (ANDA 213907).

• FDA approval · 2023-04-25
  FDA Approved: TAZAROTENE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved the original ANDA for tazarotene (TAZAROTENE) by Padagis Israel Pharmaceuticals Ltd.

• FDA approval · 2023-04-11
  FDA Approved: ADAPALENE — Supplemental Application (Actavis Pharma, Inc.)

  The FDA approved a supplemental application for adapalene from Actavis Pharma, Inc., under ANDA 201000. The action indicates regulatory appr…