Amneal has received the Food and Drug Administration’s green light for aminocaproic acid oral solution.
The product is the generic of Pfizer’s Amicar.
Amneal was previously granted a competitive Generic Therapy Designation, or CGT for its generic version of Amicar. 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, Amneal Co-CEO. “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.”
Aminocaproic acid oral solution had a market value of approximately $28 million for the 12 months ended June 30, 2019, according to IQVIA.