Acorda Receives Refusal to File Letter from FDA for INBRIJA™ (CVT-301, levodopa inhalation powder) New Drug Application
Acorda Therapeutics, Inc. (ACOR)
Last acorda therapeutics, inc. earnings: 2/13 07:00 am
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Source: Business Wire
ARDSLEY, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it received a Refusal to File (RTF) letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for INBRIJA. INBRIJA is an investigational treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. Upon its preliminary review, FDA determined that the NDA, submitted on June 26, 2017, was not sufficiently complete to permit a substantive review. 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. FDA also requested additional information at resubmission, which was not part of the basis for the RTF. The Company will seek immediate guidance, including a Type A meeting w
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ACOR
Sec Filings
- 4/4/24 - Form 8-K
- 3/13/24 - Form 8-K
- ACOR's page on the SEC website