
USFDA11 May 2024, 07:37 pm
Zydus Lifesciences Receives Final USFDA Approval for Dexamethasone Tablets USP, 1 mg
AI Summary
Zydus Lifesciences Limited has received final approval from the US Food and Drug Administration (USFDA) to market Dexamethasone Tablets USP, 1 mg in the United States. 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 in the previous year. With this approval, Zydus now has a total of 395 approvals and has filed over 460 ANDAs since the commencement of the filing process in FY 2003-04.
Key Highlights
- Zydus Lifesciences Limited receives final approval from USFDA for Dexamethasone Tablets USP, 1 mg
- 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
- This is the 395th approval for Zydus Lifesciences
- Zydus has filed over 460 ANDAs since the commencement of the filing process in FY 2003-04