BRIDGEWATER, N.J.–(BUSINESS WIRE)–#CDMO–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 version of RECTIV® (nitroglycerin) ointment, 0.4%, with 180 days Competitive Generic Therapy (CGT) exclusivity. Cosette will imminently commence commercial shipments, triggering the 180 days exclusivity.
Apurva Saraf, President and CEO of Cosette Pharma, stated, “This is a pivotal product approval, and a testament to our unwavering dedication to R&D, operational excellence and innovation. This is Cosette’s 24th new product launch and our 3rd CGT approval in the last two years. We look forward to continuing to leverage our solid R&D efforts through our state-of-the-art IVRT/IVPT labs, our manufacturing facility in Lincolnton, NC, complimented with our business development efforts to continue to deliver high-quality, affordable medications.”
Cosette currently has several products in active development, and several complex product ANDAs pending FDA approval. 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.
According to IQVIA™, U.S. annual sales of nitroglycerin ointment 0.4% for the 12 months ended January 2024 were approximately $21.2 million. RECTIV® is registered trademark of AbbVie (NYSE: ABBV)
See Package Insert (PI) for full prescribing information including Safety Information here.
About Cosette Pharmaceuticals, Inc. Cosette Pharmaceuticals, Inc. (“Cosette”) is a US-based, fully integrated pharmaceutical company with a fast-growing portfolio of branded pharmaceuticals consisting of products in women’s health, cardiology and dermatology. Cosette has a long history in quality manufacturing of complex dosage forms including topical creams, ointments, oral liquids/solutions and suppositories. Cosette has corporate and manufacturing facilities in New Jersey and North Carolina and is supported by 300+ dedicated employees across all functional areas. Cosette is backed by Avista Capital Partners, a healthcare focused private equity firm. www.cosettepharma.com. Follow us on LinkedIn.
Contacts
Kian Kazemi: sales@cosettepharma.com
Serge Ilin-Schneider: bd@cosettepharma.com