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Osmolex ER FDA Approval History

Last updated by Judith Stewart, BPharm on March 2, 2021.

FDA Approved: Yes (First approved February 20, 2018)
Brand name: Osmolex ER
Generic name: amantadine hydrochloride
Dosage form: Extended-Release Tablets
Company: Osmotica Pharmaceutical US LLC
Treatment for: Parkinson's Disease, Extrapyramidal Reaction

Osmolex ER (amantadine hydrochloride) is a proprietary formulation of immediate release and extended release amantadine for the once-a-day treatment of Parkinson’s disease and drug-induced extrapyramidal reactions.

Development timeline for Osmolex ER

Feb 19, 2018Approval FDA Approves Osmolex ER (amantadine) for the treatment of Parkinson’s Disease and Drug-Induced Extrapyramidal Reactions
Jul 22, 2015Osmotica Announces OS-320 (Osmolex ER), Has Been Awarded Orphan Drug Status by the FDA

Further information

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