- Zydus receives final approval from USFDA for Amantadine extended-release capsules 68.5 mg and tentative approval for 137 mg
- Eligible for 180 days of generic drug exclusivity for Amantadine extended-release capsules, 68.5 mg
NE BUSINESS BUREAU
AHMEDABAD, AUGUST 28
City-based Zydus Lifesciences on Wednesday said it has received approval from the US health regulator to market a generic medication to treat Parkinson’s disease.
The company has received approval from the US Food and Drug Administration (USFDA) to market Amantadine extended-release capsules (68.5 mg) and tentative approval for Gocovri (137 mg) capsules, the drug firm said in a statement.
Amantadine extended-release capsules are indicated for the treatment of dyskinesia in patients with Parkinson’s disease.
The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ – II, Zydus Lifesciences said.
“This approval makes Zydus eligible for 180 days of exclusivity for Amantadine extended-release capsules (68.5 mg), it added.
The group said it now has 400 approvals from the USFDA and has so far filed over 465 as of 30th June 2024 ANDAs since the commencement of the filing process in FY 2003-04.
