The Food and Drug Administration (FDA) has approved Cosette Pharmaceuticals’ Abbreviated New Drug Applications (ANDA) for the first generic versions of Tazorac® (tazarotene) gel, 0.05% and 0.1%.
Tazarotene Gel (0.05% and 0.1%) is a retinoid indicated for the topical treatment of plaque psoriasis of up to 20% body surface area involvement. The 0.1% formulation is also indicated for the topical treatment of mild to moderate facial acne vulgaris.
Each gram of Tazarotene Gel, 0.05% and 0.1% contains 0.5mg and 1mg of tazarotene, respectively.
Commercial shipments of the generic product have already begun, according to the Company.
Cosette Pharmaceuticals announces the approval and launch of first generic versions of Tazorac® (tazarotene) gel, 0.05% and 0.1%, with 180 days Competitive Generic Therapy (CGT) exclusivity. News release. Cosette Pharmaceuticals. Accessed Sptember 20, 2022. https://www.businesswire.com/news/home/20220920005512/en/Cosette-Pharmaceuticals-Announces-the-Approval-and-Launch-of-First-Generic-Versions-of-TAZORAC%C2%AE-tazarotene-gel-0.05-and-0.1-with-180-days-Competitive-Generic-Therapy-CGT-exclusivity