FDA Approves First Generic of Tazorac Gel

Commercial shipments are already under way of Cosette’s gel formulation of tazarotene to treat patients with acne and facial wrinkles.

The FDA has approved Cosette Pharmaceuticals’ abbreviated new drug application (ANDA) for the first generic versions of Almirall’s Tazorac (tazarotene) gel, 0.05% and 0.1%, which is used to treat psoriasis, acne, and sun damage to skin. The company has received 180 days competitive generic therapy (CGT) exclusivity.

“This approval and immediate launch represents an important milestone in the evolution of Cosette. Since we reset and refocused our R&D efforts in mid-2020, we now have several niche ANDAs pending with the FDA and look forward to the future approvals and launches,” Apurva Saraf, president and chief executive officer of Cosette Pharma, said in a press release.

Tazarotene is a retinoid product related to vitamin A. Generics of the cream formulation are available from Cosette and Taro. The lowest retail price of the cream formulation is about $40 through mail order, according to GoodRx.