Acorda Files NDA For Parkinson's Disease Candidate Inbrija
Zacks Investment Research | Jun 29, 2017 10:02PM ET
Acorda Therapeutics, Inc. (NASDAQ:ACOR) has submitted a new drug application (NDA) to FDA for its late stage pipeline candidate Inbrija (formerly known as CVT-301) for treatment of patients suffering from Parkinson’s disease. The company’s press release stated that the FDA has conditionally accepted its proposed trade name of Inbrija to market the drug on approval.
Notably, the NDA was submitted under section 505(b)(2) to FDA for the candidate. Based on current guidelines, the company expects the FDA response by September-end this year.
Inbrija is a self-administered inhaled levodopa (L-dopa) therapy for treating symptoms of OFF periods in people with Parkinson’s disease following an oral carbidopa / evodopa regimen.
However, shares of Acorda have underperformed the Zacks classified Original post
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