Acne Vulgaris

• FDA approval · 2016-07-08
  FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2016-06-23
  FDA Approved: ADAPALENE — Original Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a generic Adapalene product under an Original Approval Application, with Sun Pharmaceutical Industries listed as the manufactur…

• FDA approval · 2016-05-13
  FDA Approved: TRETINOIN CREAM — Supplemental Application (Obagi Cosmeceuticals LLC)

  FDA approved a supplemental application for Tretinoin Cream from Obagi Cosmeceuticals LLC.

• FDA approval · 2016-05-13
  FDA Approved: TRETINOIN CREAM — Supplemental Application (Obagi Cosmeceuticals LLC)

  FDA approved a supplemental application for Tretinoin Cream from Obagi Cosmeceuticals LLC. The action indicates an update to the product's a…

• FDA approval · 2016-03-25
  FDA Approved: ACANYA — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for ACANYA, a combination of clindamycin phosphate and benzoyl peroxide, manufactured by Bausch …

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• FDA approval · 2016-03-25
  FDA Approved: ZIANA — Supplemental Application (Bausch Health US, LLC)

  The FDA approved a supplemental application for ZIANA (clindamycin phosphate and tretinoin) submitted by Bausch Health US, LLC.

• FDA approval · 2016-03-23
  FDA Approved: ZIANA — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for ZIANA, a topical combination of clindamycin phosphate and tretinoin, submitted by Bausch Health …

• FDA approval · 2016-02-24
  FDA Approved: ACZONE — Original Application (Almirall, LLC)

  The FDA approved Aczone (dapsone) topical gel 5% for the treatment of acne vulgaris in patients 12 years and older. This submission represen…

• FDA approval · 2016-02-04
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

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

• FDA approval · 2016-02-04
  FDA Approved: ISOTRETINOIN — Supplemental Application (Mayne Pharma)

  The FDA approved Mayne Pharma's supplemental application for isotretinoin.

• FDA approval · 2016-02-04
  FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ABSORICA (isotretinoin) from Sun Pharmaceutical Industries, resulting in changes to the product …

• FDA approval · 2016-02-04
  FDA Approved: CLARAVIS — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approves a supplemental application for CLARAVIS (isotretinoin) from Teva Pharmaceuticals USA, Inc. The action concerns the existing iso…

• FDA approval · 2016-02-04
  FDA Approved: ZENATANE — Supplemental Application (BluePoint Laboratories)

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

• FDA approval · 2016-01-05
  FDA Approved: ADAPALENE — Original Application (CALL INC. (dba Rochester Pharmaceuticals))

  FDA approved a generic version of adapalene under ANDA 204593, allowing CALL INC. (dba Rochester Pharmaceuticals) to market adapalene for ac…

• FDA approval · 2015-12-23
  FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ABSORICA (isotretinoin) submitted by Sun Pharmaceutical Industries, Inc.

• FDA approval · 2015-12-17
  FDA Approved: TRETINOIN CREAM — Supplemental Application (Obagi Cosmeceuticals LLC)

  FDA approved a supplemental application for tretinoin cream by Obagi Cosmeceuticals LLC, updating its labeling.

• FDA approval · 2015-11-19
  FDA Approved: ACANYA — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for ACANYA (clindamycin phosphate and benzoyl peroxide) from Bausch Health US, LLC.

• FDA approval · 2015-10-08
  FDA Approved: ACANYA — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for ACANYA (clindamycin phosphate and benzoyl peroxide) from Bausch Health US, LLC.

• FDA approval · 2015-09-21
  FDA Approved: DOXYCYCLINE HYCLATE — Supplemental Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved a supplemental application for Doxycycline Hyclate by Hikma Pharmaceuticals USA Inc., indicating a change to the product's labe…

• FDA approval · 2015-09-21
  FDA Approved: CLINDAMYCIN AND BENZOYL PEROXIDE — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved a new generic clindamycin and benzoyl peroxide topical product from Padagis Israel Pharmaceuticals Ltd for the treatment of acn…

• FDA approval · 2015-09-18
  FDA Approved: ERYTHROMYCIN AND BENZOYL PEROXIDE — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved a generic topical combination product of erythromycin and benzoyl peroxide for acne under ANDA065385 by Rising Pharma Holdings,…

• FDA approval · 2015-09-10
  FDA Approved: ACANYA — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for ACANYA (clindamycin phosphate and benzoyl peroxide) from Bausch Health US, LLC.

• FDA approval · 2015-09-03
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approves a supplemental application for Amnesteem (isotretinoin) submitted by Mylan Pharmaceuticals.

• FDA approval · 2015-09-03
  FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

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

• FDA approval · 2015-09-03
  FDA Approved: ZENATANE — Supplemental Application (BluePoint Laboratories)

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