FDA Approves Osmotica’s Extended-Release Amantadine for Movement Disorders
Abstract
FDA Approves Osmotica’s Extended-Release Amantadine for Movement Disorders
Osmotica Pharmaceutical in February announced that the Food and Drug Administration has approvedextended-releaseamantadine tablets (Osmolex ER) for the treatment of both Parkinson's disease and drug-induced extrapyramidal symptoms in adults.
Osmolex ER will be available in three once-daily dosage options: 129 mg, 193 mg, and 258 mg tablets, with a maximum daily dose of 322 mg. ■