Amneal Receives Abbreviated New Drug Application Approval for Acyclovir Cream, 5%
11 November 2020 - - US-based pharmaceutical company Amneal Pharmaceuticals, Inc. (NYSE: AMRX) has received approval for its Abbreviated New Drug Application from the US Food and Drug Administration for Acyclovir Cream, 5%, the company said.

Acyclovir Cream, 5%, is the generic version of Zovirax for treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.

The product is available by prescription only and is associated with mild side effects such as nausea.

According to IQVIA, a leading healthcare data and analytics provider, US annual sales for Acyclovir Cream, 5%, for the 12 months ended September 2020 were approximately USD 67m.

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 a 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.