Drug news

FDA approves Osmolex ER for Parkinson's disease.- Osmotica Pharma.

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Last updated:21st Feb 2018

Published:21st Feb 2018

Source: Pharmawand

Osmotica Pharmaceutical announced that the FDA has approved Osmolex ER (amantadine HCl extended release), 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 Osmolex ER tablet is taken once-daily in the morning, releasing amantadine throughout the day.

Approval is based on Osmotica�s clinical program for Osmolex ER which included two Phase III trials evaluating two doses (240mg and 320mg) in 324 aggregate patients.

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