The FDA approved Osmotica Pharmaceutical's drug Osmolex ER to treat Parkinson's disease Monday.
Here are four things to know.
1. Osmolex contains both immediate-release and extended-release forms of the drug amantadine, a known treatment for Parkinson's. Patients take the pill once-daily in the morning.
2. The FDA also approved Osmolex to treat patients with drug-induced movement disorders.
3. The drug's formulation is protected by three patents valid through March 2030.
4. Osmotica Pharmaceutical said it is finalizing commercialization plans to launch the drug as soon as possible, though the drugmaker did not share an exact date.
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