FDA Rejects Acorda's NDA For PLUMIAZTM - Quick Facts

(RTTNews) - Acorda Therapeutics, Inc. (ACOR) Friday said the U.S. Food and Drug Administration or FDA rejected its New Drug Application or NDA for PLUMIAZTM or diazepam, a nasal spray for the treatment of people with epilepsy who experience cluster seizures.

The FDA has asked the company to review its application.Acorda said, it is currently developing a response to address the items outlined in the letter. Further the company said, based on the requirements for approval outlined in the letter, it does not expect PLUMIAZ to receive FDA approval in 2014.