Amantadine Gains FDA Approval for Parkinson's Disease

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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