Minocycline 1.5% topical foam (Zilxi)

On 28 May 2020, USFDA approved Menlo therapeutics’ Zilxi™ (Minocycline 1.5% topical foam) for the treatment of inflammatory lesions of rosacea in adults. As mentioned in Menlo’s press release (See here), Zilxi is the first minocycline product of any kind to be approved by the FDA for use in rosacea.

Currently, Menlo therapeutics markets Minocycline 4% topical foam product (Amzeeq) for inflammatory lesions of non-nodular moderate to severe acne vulgaris.

Zilxi and Amzeeq contains the same excipients. They differ from each other in strength and Indications.

Menlo’s launch plan: Menlo anticipates having ZILXI available for prescribing by Q4 2020. (See here)

See below to find out how Zilxi is different from Amzeeq:

 

Want to read more about Amzeeq, then see here.

Want to read more on other 505(b)(2) approvals of 2020, then click here.

List of 505(b)(2) approvals of 2019 is available here.