USFDA28 Aug 2024, 02:41 am
Zydus Lifesciences Receives Final USFDA Approval for Amantadine Extended-Release Capsules
AI Summary
Zydus Lifesciences Ltd has received final approval from the USFDA for Amantadine extended-release capsules, 68.5 mg, and tentative approval for 137 mg. The drug is indicated for the treatment of dyskinesia in patients with Parkinson’s disease. The manufacturing will be done at the group’s formulation manufacturing facility in Ahmedabad SEZ - I, India. This approval makes Zydus eligible for 180 days of exclusivity for Amantadine extended-release capsules, 68.5 mg. Zydus now has 400 approvals and has so far filed over 465 ANDAs since the commencement of the filing process in FY 2003-04.
Key Highlights
- Zydus Lifesciences receives final approval from USFDA for Amantadine extended-release capsules, 68.5 mg, and tentative approval for 137 mg
- The drug is indicated for the treatment of dyskinesia in patients with Parkinson’s disease
- The manufacturing will be done at the group’s formulation manufacturing facility in Ahmedabad SEZ - I, India
- This approval makes Zydus eligible for 180 days of exclusivity for Amantadine extended-release capsules, 68.5 mg
- Zydus now has 400 approvals and has so far filed over 465 ANDAs since the commencement of the filing process in FY 2003-04