USFDA23 May 2025, 05:21 pm
Zydus Lifesciences Receives Final USFDA Approval for Isotretinoin Capsules USP
AI Summary
Zydus Lifesciences Ltd. has received final approval from the USFDA for Isotretinoin Capsules USP, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg. The capsules are indicated to treat severe, disfiguring nodular acne and will be produced at the Group’s manufacturing site at Moraiya, Ahmedabad. The group now has 427 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04. Isotretinoin capsules had annual sales of USD 115.4 mn in the United States (IQVIA MAT March 2025).
Key Highlights
- Zydus Lifesciences receives final approval from USFDA for Isotretinoin Capsules USP
- Indicated to treat severe, disfiguring nodular acne
- To be produced at the Group’s manufacturing site at Moraiya, Ahmedabad
- Isotretinoin capsules had annual sales of USD 115.4 mn in the United States (IQVIA MAT March 2025)
- Zydus now has 427 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04