Amneal Pharmaceuticals 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.
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“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.