drugset / Press release

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

2022-09-20 · Cosette Pharmaceuticals, Inc. · original cosettepharma.com ↗

Bridgewater, NJ, United States. September 20, 2022. Cosette Pharmaceuticals, Inc (“Cosette”) announced that the U.S. Food and Drug Administration (FDA) has approved the Abbreviated New Drug Applications (ANDA) for the first generic versions of TAZORAC® (tazarotene) gel, 0.05% and 0.1%, with 180 days Competitive Generic Therapy (CGT) exclusivity. Cosette has already commenced commercial shipments, triggering the 180 days exclusivity. Apurva Saraf, President and CEO of Cosette Pharma, stated, “this approval and immediate launch represents an important milestone in the evolution of Cosette, and reaffirms our commitment to world class R&D and operational excellence. 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” This launch will enable Cosette to continue to build upon its unparalleled quality track record and leverage its United States based manufacturing site in Lincolnton, NC. About Cosette Pharmaceuticals, Inc.: Cosette Pharmaceuticals, Inc. is a US-based, fully integrated pharmaceutical company with capabilities in product development, manufacturing, and commercial operations. The current products focus on complex dosage forms including topical creams, ointments, oral liquids/solutions, suppositories, and injectables. Cosette has a long history of quality manufacturing, consistent supply, and commercialization success, including two sites (New Jersey and North Carolina) supported by more than 350+ dedicated employees across all functional areas. Cosette has a fast-growing portfolio of branded pharmaceuticals, consisting of products in cardiology, women’s health and pediatrics. Cosette is backed by Avista Capital Partners, a healthcare focused private equity firm. www.cosettepharma.com Follow us on LinkedIn. TAZORAC ® is registered trademark of Almirall Contacts: Serge Ilin-Schneider: [email protected] Kian Kazemi: [email protected] RECENT POSTS Cosette Appoints Andrew Adams as Vice President, Supply Chain & Sourcing September 10, 2026 Cosette Pharmaceuticals Appoints Erika Tooman as Senior Vice President, General Counsel April 28, 2026 Cosette Pharmaceuticals Appoints Danielle DeBoer as Senior Vice President, Human Resources April 14, 2026 Cosette Pharmaceuticals Expands Branded Portfolio through Acquisition of SYMPAZAN® and Additional Products from Assertio April 8, 2026 Cosette Pharmaceuticals Appoints Joseph Skelton as Senior Vice President, Corporate Development and Strategy March 18, 2026

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