Zydus receives USFDA approval for Dexamethasone

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Dexamethasone Tablets USP, 1 mg (USRLD: Dexamethasone Tablets).

Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions, skin diseases, eye problems, breathing problems, bowel disorders, cancer and immune system disorders.

The product will be manufactured at the group’s formulation manufacturing facility at Baddi, Himachal Pradesh. Dexamethasone Tablets USP, 1 mg had annual sales of $ 1.8 million in the United States (IQVIA MAT March 24). The group now has 395 approvals and has so far filed over 460 (as of 31st December, 2023) ANDAs since the commencement of the filing process in FY 2003-04.