FDA pushes back decision date for Acorda ’s Parkinson’s drug

Acorda Therapeutics (NSDQ:ACOR) said today that the FDA pushed back its goal date for the agency’s review of Acorda’s inhaled levodopa Parkinson’s therapy. The FDA’s date to make a decision about Acorda’s Inbrija product was moved from Oct. 5, 2018 to Jan. 5, 2019. The Ardsley, N.Y.-based company said the extension is related to submissions it made in response to requests from the FDA for additional data on chemistry, manufacturing & controls. Get the full story at our sister site, Drug Delivery Business News. The post FDA pushes back decision date for Acorda’s Parkinson’s drug appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Drug-Device Combinations Featured Food & Drug Administration (FDA) Neurological Pharmaceuticals Regulatory/Compliance Wall Street Beat Acorda Therapeutics Source Type: news