Zydus Lifesciences Gets USFDA Nod for Generic Parkinson's Drug
Zydus Lifesciences has received USFDA approval for Amantadine extended-release capsules, a generic medication for Parkinson's disease, providing 180 days of exclusivity.
New Delhi, Aug 28 (PTI) 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 Gujarat-based group said it now has 400 approvals from the USFDA.
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 Gujarat-based group said it now has 400 approvals from the USFDA.
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