Zydus Lifesciences gets final nods for Dexamethasone Tablets

08 Feb 2024 Evaluate

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.

Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.

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