Amneal Pharmaceuticals issued the following announcement on Sep. 5.
Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its generic version of Amicar® (aminocaproic acid oral solution) 0.25g/mL.
Amneal 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.
“We are pleased to be able to utilize the FDA’s Competitive Generic Therapy approval pathway to provide patients with expanded access to a product with limited competition,” said Chintu Patel, Co-CEO of Amneal. “Going forward, we will continue to leverage our development and regulatory expertise to take advantage of similar opportunities and expand competition and patient access to important generic medicines.”
According to IQVIA™, U.S market annual sales for the 12 months ended June 30, 2019 for aminocaproic acid oral solution was estimated to be approximately $28 million.
About Amneal
Amneal 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.
Amneal 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.
Original source can be found here.
