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Zilxi FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 28, 2021.

FDA Approved: Yes (First approved May 28, 2020)
Brand name: Zilxi
Generic name: minocycline
Dosage form: Topical Foam
Previous Name: FMX103
Company: Foamix Pharmaceuticals Ltd.
Treatment for: Rosacea

Zilxi (minocycline) is a topical tetracycline formulation indicated for the treatment of inflammatory lesions of rosacea in adults.

Development timeline for Zilxi

DateArticle
May 29, 2020Approval FDA Approves Zilxi (minocycline) Topical Foam for the Treatment of Rosacea
Oct 17, 2019Foamix Announces FDA Acceptance of its New Drug Application for FMX103 Minocycline Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea
Aug  5, 2019Foamix Submits New Drug Application to U.S. FDA for FMX103 for the Treatment of Moderate-to-Severe Papulopustular Rosacea

Further information

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