US FDA grants tentative approval to Zydus’s Amantadine extended-release capsules

The United States Food and Drug Administration (FDA) has granted tentative approval to market Zydus Pharma’s Amantadine extended-release capsules USP 68.5 mg and 137 mg.

Amantadine is indicated for the treatment of dyskinesia (sudden uncontrolled movements) in patients with Parkinson’s disease who are treated with levodopa therapy, with or without dopaminergic medicines. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ.