Acne Vulgaris

• FDA approval · 2018-11-19
  FDA Approved: AZELAIC ACID — Original Application (Glenmark Pharmaceuticals Inc., USA)

  FDA approved Glenmark's azelaic acid product under an Original Application (ANDA 204637).

• FDA approval · 2018-11-19
  FDA Approved: AZELAIC ACID — Original Application (Actavis Pharma, Inc.)

  FDA approved Actavis Pharma's azelaic acid product under an Original Application (ANDA), providing a generic option for azelaic acid topical…

• FDA approval · 2018-10-17
  FDA Approved: ADAPALENE AND BENZOYL PEROXIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved Sun Pharmaceutical's original application for a generic adapalene and benzoyl peroxide topical product for acne vulgaris.

• FDA approval · 2018-10-01
  FDA Approved: SEYSARA — Original Application (Almirall, LLC)

  The FDA approved SEYSARA (sarecycline hydrochloride) from Almirall, LLC under an Original New Drug Application, for the treatment of acne vu…

• FDA approval · 2018-08-31
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for AMNESTEEM (isotretinoin) submitted by Mylan Pharmaceuticals. This action approves changes to…

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• FDA approval · 2018-08-31
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for CLARAVIS (isotretinoin) submitted by Teva Pharmaceuticals USA, Inc. to update the labeling.

• FDA approval · 2018-08-31
  FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)

  FDA approved Mayne Pharma's supplemental application for isotretinoin.

• FDA approval · 2018-08-31
  FDA Approved: ZENATANE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for ZENATANE (isotretinoin) filed by BluePoint Laboratories, approving changes to the existing label…

• FDA approval · 2018-08-31
  FDA Approved: ISOTRETINOIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approves a supplemental application for isotretinoin filed by Amneal Pharmaceuticals NY LLC.

• FDA approval · 2018-08-31
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2018-06-05
  FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's generic clindamycin phosphate and benzoyl peroxide topical product for acne vulgaris.

• FDA approval · 2018-06-01
  FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for a generic clindamycin phosphate and benzoyl peroxide topical product, expanding access for a…

• FDA approval · 2018-05-25
  FDA Approved: CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved Sun Pharmaceutical's generic clindamycin phosphate and benzoyl peroxide gel for acne vulgaris (original application).

• FDA approval · 2018-05-23
  FDA Approved: ADAPALENE AND BENZOYL PEROXIDE GEL, 0.1%/2.5% — Original Application (Encube Ethicals, Inc.)

  FDA approved Encube Ethicals' adapalene 0.1%/benzoyl peroxide 2.5% gel as an original ANDA product for acne vulgaris.

• FDA approval · 2018-05-18
  FDA Approved: ACZONE — Supplemental Application (Almirall, LLC)

  The FDA approved a supplemental application for ACZONE (dapsone) submitted by Almirall, LLC.

• FDA approval · 2018-05-02
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a supplemental application for CLARAVIS (isotretinoin) from Teva Pharmaceuticals USA, Inc. This approval covers changes to …

• FDA approval · 2018-05-02
  FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)

  FDA approved Mayne Pharma's supplemental application for isotretinoin. The action indicates a labeling or formulation update under an approv…

• FDA approval · 2018-05-02
  FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  The FDA approved a supplemental application for ABSORICA (isotretinoin) from Sun Pharmaceutical Industries, Inc. to modify or expand its lab…

• FDA approval · 2018-05-02
  FDA Approved: ZENATANE — Supplemental Application (BluePoint Laboratories)

  FDA approved a supplemental application for ZENATANE (isotretinoin) submitted by BluePoint Laboratories.

• FDA approval · 2018-05-02
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2018-05-02
  FDA Approved: ISOTRETINOIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)

  FDA approves a supplemental application for isotretinoin from Amneal Pharmaceuticals NY LLC.

• FDA approval · 2018-04-23
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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

• FDA approval · 2018-04-23
  FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)

  FDA approves a supplemental application for isotretinoin submitted by Mayne Pharma, bringing changes to the product under its existing appro…

• FDA approval · 2018-04-23
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for AMNESTEEM (isotretinoin) filed by Mylan Pharmaceuticals Inc.

• FDA approval · 2018-04-23
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

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