Nodular Acne

• FDA approval · 2023-03-24
  FDA Approved: AMNESTEEM — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for AMNESTEEM (isotretinoin) submitted by Mylan Pharmaceuticals Inc. The action represents an ap…

• FDA approval · 2021-03-31
  FDA Approved: ISOTRETINOIN — Original Application (Actavis Pharma, Inc.)

  FDA approves Actavis's original ANDA for isotretinoin (generic) for the treatment of severe acne. This confirms a generic version of isotret…

• FDA approval · 2020-12-09
  FDA Approved: ABSORICA LD — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approves a supplemental application for ABSORICA LD (isotretinoin) by Sun Pharmaceutical Industries, Inc., typically related to labeling…

• 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 label_change · 2017-06-17
  FDA Approved: ABSORICA — Supplemental Application (Sun Pharmaceutical Industries, Inc.)

  FDA approved a supplemental application for ABSORICA (isotretinoin) from Sun Pharmaceutical Industries, Inc., resulting in updates to the la…

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• CLINICAL_TRIALS trial_result · 2014-07-04
  Clinical Trial Update: Efficacy and Safety of CIP-Isotretinoin in Patients With Severe Recalcitrant Nodular Acne [Phase 3]

  Phase 3 trial results for CIP-Isotretinoin in patients with severe recalcitrant nodular acne show efficacy and safety data. The results were…