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# FDA Approves Osmotica NDA for Parkinson’s
- URL: https://www.fdaweb.com/fda-approves-osmotica-nda-for-parkinsons/
- Published: 2018-02-20T12:00:00.000Z
- Updated: 2026-09-14T23:23:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140798

FDA has approved an Osmotica Pharmaceutical NDA for Osmolex ER (amantadine extended release tablets) for treating Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients. Extrapyramidal symptoms (movement disorders) are known side effects of many common medications. The drug’s labeling says it is contraindicated in patients with low creatinine clearance. It also warns that patients treated with amantadine have reported falling asleep while engaged in activities of daily living, including the operation of motor vehicles, which sometimes has resulted in accidents.