Zydus gets tentative USFDA approval for Dexamethasone Tablets USP, 1 mg
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
Zydus Lifesciences 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 $1.8 million 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.
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