Zydus receives Tentative Approval from the USFDA for Dexamethasone Tablets USP, 1 mg

Zydus receives Tentative Approval from the USFDA for Dexamethasone Tablets USP, 1 mg

By: IPP Bureau

Last updated : February 10, 2024 11:06 am



Dexamethasone is used to treat conditions such as arthritis, blood/hormone disorders, allergic reactions


Zydus Lifesciences Limited has received tentative approval from the United States Food and Drug Administration (USFDA) to manufacture and 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 USD 1.8 mn in the United States (IQVIA Dec. Nov. 2023).

The group now has 387 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences Limited

First Published : February 10, 2024 12:00 am