Generic Amicar Approved

September 6, 2019 – The U.S. FDA has approved Amneal Pharmaceuticals' generic for Akorn’s Amicar® (aminocaproic acid) 0.25g/mL oral solution. The product was approved under the FDA's Competitive Generic Therapy (CGT) program, which is designed to accelerate review of generics for drugs that lack sufficient generic competition.

Amneal’s product is the first generic to become available for Amicar oral solution in the United States. Aminocaproic acid is used to counteract the effects of drugs that inhibit fibrin, a protein needed to form blood clots. If these anti-clotting drugs are too successful at inhibiting fibrin, they can contribute to excessive bleeding. ecommended dosing with aminocaproic acid oral solution is four teaspoons in the first hour, followed by one teaspoon each hour until the bleeding stops.

Launch and pricing plans are not yet available.