FDA provides a refusal to file letter in response to application for Inbrija (inhaled levodopa) in Parkinson's disease.-Acorda Therapeutics.
Acorda Therapeutics announced that it received a Refusal to File (RTF) letter from the FDA regarding its New Drug Application (NDA) for Inbrija (inhaled levodopa). Upon its preliminary review, FDA determined that the NDA, submitted on June 26, 2017, was not sufficiently complete to permit a substantive review.
The FDA specified two reasons for the RTF: first, the date when the manufacturing site would be ready for inspection, and, second, a question regarding the submission of the drug master production record. The FDA also requested additional information at resubmission, which was not part of the basis for the RTF.
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