BRIDGEWATER, N.J., Feb. 19, 2018 — Osmotica Pharmaceutical US LLC (“Osmotica” or the “Company”), a privately-held specialty pharmaceutical company developing novel central nervous system (CNS) treatments utilizing its proprietary osmotic drug delivery platform, announced today that the U.S. Food and Drug Administration (FDA) has approved OSMOLEX ER™, an amantadine extended release tablet, for the treatment of Parkinson’s disease and for the treatment of drug-induced extrapyramidal reactions in adult patients. Extrapyramidal symptoms are known side effects of many common medications.
“The FDA’s approval of OSMOLEX ER provides a new treatment option for those patients suffering from Parkinson’s disease and adults who have extrapyramidal reactions, or movement disorders, that are caused by certain medicines. We are eager to make OSMOLEX ER available to physicians and patients in the U.S.,” stated Brian Markison, Chief Executive Officer of Osmotica.
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