5 December 2019 - - US-based drugmaker Amneal Pharmaceuticals, Inc. (NYSE: AMRX) has received final US Food and Drug Administration approval on its Abbreviated New Drug Applications for generic versions of Revatio (sildenafil citrate) for Oral Suspension 10 mg/ml and Amicar (aminocaproic acid) Tablets USP, 500 mg, the company said.

Amneal has immediately initiated commercialisation activities.

Amneal was previously granted a Competitive Generic Therapy designation for its generic version of Amicar by the FDA. As the first approved application, Amneal has been granted 180 days of CGT exclusivity.

According 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 USD 180m and USD 23m, respectively.

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.