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May 2, 2014
06:07 EDTACORAcorda Therapeutics reports FDA issues CRL for Plumiaz
Acorda Therapeutics announced that the FDA has issued a Complete Response Letter, or CRL, for the New Drug Application for Plumiaz Nasal Spray for the treatment of people with epilepsy who experience cluster seizures. A CRL is a communication from the FDA that informs a company that their review of the NDA is complete and the application cannot be approved in its present form. The company is currently developing a response to address the items outlined in the letter.
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