FDA approves first-ever topical form of minocycline, Amzeeq

21 October 2019
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The US Food and Drug Administration has approved Israel-headquartered skincare specialist Foamix Pharmaceuticals’ (Nasdaq: FOMX) novel Amzeeq (minocycline) topical foam, 4%.

Amzeeq, formerly known as FMX101, is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients nine years of age and older and is the first topical minocycline to be approved by the FDA for any condition.

“The FDA approval of Amzeeq is a milestone moment in dermatology and the most significant advancement with minocycline in almost 50 years,” said David Domzalski, chief executive of Foamix, adding: “We are proud that our proprietary technology platform has led to this new treatment option, which we believe can help address unmet treatment needs for moderate to severe acne patients. We are looking forward to bringing Amzeeq to market in January 2020, and to our company’s first commercial launch.”

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