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.
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.