BRIDGEWATER, N.J. — Amneal Pharmaceuticals announced on Wednesday that it is launching dexamethasone, 4mg and 6 mg, following Abbreviated New Drug Application (ANDA) approval from the U.S. Food and Drug Administration.
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, cochief 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.