Amantadine Gains FDA Approval for Parkinson's Disease

Amantadine previously received FDA approval for antiviral and antiparkinsonian treatment.

The FDA has approved an amantadine extended release tablet (OSMOLEX ER) for the treatment of Parkinson’s disease (PD) and drug-induced extrapyramidal reactions in adult patients.

The tablet, manufactured by Osmotica Pharmaceutical, is a drug formulation of both immediate and extended release amantadine that utilizes the company’s patented Osmodex technology to provide once-daily therapy for adult patients with PD and drug-induced involuntary movement disorders, such as tardive dyskinesia (TD).

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