First Generic Version of Clindagel Gets FDA Approval

First Generic Version of Clindagel Gets FDA Approval

The Food and Drug Administration has approved Solaris Pharma’s Abbreviated New Drug Application for clindamycin phosphate EQ 1% topical gel, the first generic version of Clindagel® (Bausch Health).

Clindamycin phosphate EQ 1% gel is indicated for topical application in the treatment of acne vulgaris. The product contains 10mg of clindamycin, a lincosamide antibiotic, per gram in a gel vehicle.  Safety and effectiveness of the topical agent have not been established in children under 12 years of age.

The generic version is supplied in a 75mL bottle and is expected to be available immediately.

Reference

Solaris Pharma receives approval for first generic version of Clindagel® (clindamycin phosphate EQ 1%). News release. August 23, 2021. https://www.globenewswire.com/news-release/2021/08/23/2284805/0/en/Solaris-Pharma-Receives-Approval-for-First-Generic-Version-of-Clindagel-clindamycin-phosphate-EQ-1.html.


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Source: Medical Bag https://www.medicalbag.com/home/news/first-generic-version-of-clindagel-gets-fda-approval/

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