Amneal Launches Generic Dexamethasone Following ANDA Approval by FDA

Dexamethasone, the generic version of Decadron®, is a well-established anti-inflammatory glucocorticoid steroid used to treat several medical conditions, including respiratory complications associated with COVID-19.

Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced that it is launching dexamethasone, 4mg and 6 mg, following Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration (FDA).

Dexamethasone, the generic version of Decadron®, is a well-established anti-inflammatory glucocorticoid steroid used to treat several medical conditions, including respiratory complications associated with COVID-19.

“Today’s approval and launch of dexamethasone reflects the continued execution of our innovation agenda. Expanding access to essential therapies, particularly in the treatment of COVID-19, is core to our mission at Amneal and we are pleased to play our part,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

According to IQVIA™, a leading healthcare data and analytics provider, U.S. annual sales for 4 mg and 6 mg dexamethasone tablets for the 12 months ended August 2021 were approximately $63 million.

Dexamethasone tablets can produce reversible hypothalamic-pituitary adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. Elevated blood pressure, sodium and water retention, and increased excretion of potassium, have also been reported.

Mild to severe infection with exacerbation may occur with the use of dexamethasone tablets alone or in combination with other immunosuppressive agents. Dexamethasone is contraindicated in patients hypersensitive to any components of this product.

See Package Insert (PI) for full prescribing information including Safety Information: https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=ac71f888-c83a-46a5-921c-1ebdf6cfadc1&type=display

About Amneal

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 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 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. For more information, visit www.amneal.com.

SOURCE: Amneal Pharmaceuticals