Acorda Announces FDA Acceptance of New Drug Application for INBRIJA™ (levodopa inhalation powder)
Acorda Therapeutics, Inc. (ACOR)
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Source: Business Wire
ARDSLEY, N.Y.--(BUSINESS WIRE)-- Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for INBRIJA. INBRIJA is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a target date of October 5, 2018. “OFF periods greatly disrupt the lives of people living with Parkinson’s, and there is a significant need for new treatments in this community,” said Burkhard Blank, M.D., Chief Medical Officer of Acorda. “We are excited about the potential to bring this highly innovative treatment option to people living with Parkinson’s, and look forward to working with the FDA throughout the review process.” The NDA for INBRIJA includes data from a Phase 3
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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