Amneal Launches Generic Fluphenazine Following ANDA Approval by FDA
10 July 2020 - - US-based pharmaceutical company Amneal Pharmaceuticals, Inc. (NYSE: AMRX) has received Abbreviated New Drug Application approval from the US Food and Drug Administration for a generic version of Fluphenazine Hydrochloride Tablets USP, 1 mg, 2.5 mg, 5 mg, and 10 mg, the company said.

Fluphenazine Hydrochloride is the generic version of Prolixin for treatment of schizophrenia. Amneal immediately initiated commercialisation activities across all dosages.

According to IQVIA, a healthcare data and analytics provider, US annual sales for Fluphenazine Hydrochloride Tablets for the 12 months ended May 2020 were approximately USD 143m.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully-integrated pharmaceutical company focused on the development, manufacturing and distribution of generic and specialty drug 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 approximately 250 product families and is expanding its portfolio to include complex dosage forms, including biosimilars, in a range of therapeutic areas.

The company also markets a portfolio of branded pharmaceutical products through its Specialty segment focused principally on central nervous system and endocrine disorders.

The company also owns 65% of AvKARE. AvKARE provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, primarily focused on serving the Department of Defense and the Department of Veterans Affairs.

AvKARE is also a packager and wholesale distributor of pharmaceuticals and vitamins to its retail and institutional customers who are located throughout the United States focused primarily on offering 340b-qualified entities products to provide consistency in care and pricing.