Amzeeq FDA Approval History
Last updated by Judith Stewart, BPharm on Nov 27, 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 Timeline for Amzeeq
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