Business
Amneal Announces the Approval and Launch of Generic Revatio® for Oral Suspension and Generic Amicar® Tablets
- Company granted 180 days of exclusivity under FDA Competitive Generic Therapy approval pathway for Generic Amicar - BRIDGEWATER, N.J.--(BUSINESS WIRE)--
About this update from Amneal Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Company granted 180 days of exclusivity under FDA Competitive Generic Therapy approval pathway for Generic Amicar - \n\n BRIDGEWATER, N.J.--(BUSINESS WIRE)--\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received final U.S. Food and Drug Administration (“FDA”) approval on its Abbreviated New Drug Applications (“ANDA”) for generic versions of Revatio® (sildenafil citrate) for Oral Suspension 10 mg/ml and Amicar® (aminocaproic acid) Tablets USP, 500 mg. Amneal has immediately initiated commercialization activities.\n\n\n“We are pleased to bring these important medications to patients and healthcare providers,” said Chintu Patel, Co-CEO of Amneal. “Our large and diverse pipeline has now delivered 36 new generic products to the market in 2019 across numerous dosage forms.”\n\n\nAmneal was previously granted a Competitive Generic Therapy (“CGT”) designation for its generic version of Amicar® by the FDA. As the first approved application, Amneal has been granted 180 days of CGT exclusivity.\n\n\nAccording to IQVIA™, U.S market annual sales for the 12 months ended September 30, 2019, for sildenafil citrate oral suspension and aminocaproic acid 500 mg tablets were estimated to be approximately $180 million and $23 million, respectively.\n\n\nAbout Amneal\n\n\nAmneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is an integrated pharmaceutical company focused on developing, manufacturing and distributing generic, brand and biosimilar products. The Company has operations in North America, Asia, and Europe, working together to bring high-quality medicines to patients primarily within the United States.\n\n\nAmneal has an extensive portfolio of more than 300 generic medicines and is expanding its portfolio to include complex dosage forms in a broad range of therapeutic areas. The Company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system disorders and parasitic infections. For more information, visit www.amneal.com.\n\n\nSafe Harbor Statement\n\n\nCertain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management...