Zydus gets USFDA nod for Dexamethasone Tablets USP, 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg and Dexamethasone Tablets USP, 2 mg

Zydus Lifesciences has received final approvals from the United States Food and Drug Administration (USFDA) to manufacture and market Dexamethasone Tablets USP, 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg (USRLD: Decadron® Tablets) and Dexamethasone Tablets USP, 2 mg (USRLD: Dexamethasone Tablets).

Dexamethasone is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, asthma, blood or bone marrow problems, kidney problems, skin conditions, and flare-ups of multiple sclerosis. The products will be manufactured at the group’s formulation manufacturing facility at Baddi, Himachal Pradesh.

Dexamethasone Tablets USP, 0.5 mg, 0.75 mg, 1.5 mg, 4 mg and 6 mg had annual sales of $22 million and Dexamethasone Tablets USP, 2 mg has annual sales of $6 million in the United States (IQVIA Dec. Nov. 2023).

The group now has 386 approvals and has so far filed over 448* ANDAs since the commencement of the filing process in FY 2003-04.