Zydus Receives Final USFDA Approval For Amantadine Extended-Release Capsules
Additionally, it has received tentative approval for the 137 mg dosage strength
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Amantadine extended-release capsules at a dosage of 68.5 mg.
In a press statement on Wednesday, the company informed that additionally, it has received tentative approval for the 137 mg dosage strength. These approvals relate to Zydus’s generic version of Gocovri (amantadine) extended-release capsules.
Amantadine extended-release capsules are indicated for the treatment of dyskinesia in patients with Parkinson’s disease who are receiving levodopa-based therapy, either alone or in combination with other dopaminergic medications. The capsules will be produced at Zydus's formulation manufacturing facility located in Ahmedabad SEZ - II, India.
The approval grants Zydus a 180-day exclusivity period for marketing the 68.5 mg dosage of Amantadine extended-release capsules, the press statement added.
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