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Amzeeq Approval History

Reviewed by J.Stewart BPharm Last updated on Oct 18, 2019.

FDA Approved: Yes (First approved October 18, 2019)
Brand name: Amzeeq
Generic name: minocycline
Dosage form: Topical Foam
Company: Foamix Pharmaceuticals
Treatment for: Acne

Amzeeq (minocycline) is a topical foam formulation of the approved tetracycline drug minocycline indicated for the treatment of moderate to severe acne vulgaris in patients 9 years of age and older.

  • Amzeeq is the first topical formulation of minocycline to be approved by the FDA for any condition. Minocycline has been approved in several dosage forms for the treatment of many different conditions caused by bacterial infections since its first approval in capsule form under the brand name Minocin in 1971. Other brands of minocycline include Dynacin, Arestin, Solodyn, Ximino, and Minolira.
  • Amzeeq topical foam is applied to the skin once daily, at least one hour before bedtime.
  • The propellant in Amzeeq is flammable and patients using the product should avoid smoking, and should stay away from fire and flames, during and immediately following application.
  • Tetracyclines such as minocycline can cause photosensitivity reactions. Patients using Amzeeq should use sunscreen and other sun protection measures, and minimize or avoid exposure to natural or artificial sunlight during treatment. Treatment should be stopped altogether at the first evidence of sunburn.
  • The most common side effect of Amzeeq is headache.

Development History and FDA Approval Process for Amzeeq

DateArticle
Oct 18, 2019Approval FDA Approves Amzeeq (minocycline) Topical Foam for the Treatment of Moderate to Severe Acne
Mar  7, 2019Foamix Announces FDA Acceptance of New Drug Application for FMX101 Minocycline Foam for the Treatment of Moderate-to-Severe Acne
Dec 21, 2018Foamix Submits New Drug Application to U.S. FDA Seeking Approval of FMX101 in Treatment of Moderate-to-Severe Acne
May  1, 2017Foamix Pharmaceuticals Announces Plans for Additional Phase 3 Trial for FMX101 in Moderate to Severe Acne

Further information

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