Osmolex ER Approval History
- FDA approved: Yes (First approved February 20th, 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 History and FDA Approval Process for Osmolex ER
|Feb 19, 2018||FDA Approves Osmolex ER (amantadine) for the treatment of Parkinson’s Disease and Drug-Induced Extrapyramidal Reactions|
|Jul 22, 2015||Osmotica Announces OS-320 (Osmolex ER), Has Been Awarded Orphan Drug Status by the FDA|
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