Acorda Therapeutics,Inc. (NASDAQ:ACOR) Files An 8-K Other EventsItem 8.01Other Events
On December 7, 2017, Acorda Therapeutics, Inc. (the “Company”) issued a press release announcing the resubmission of its New Drug Application (“NDA”) for INBRIJA to the U.S. Food and Drug Administration (“FDA”). INBRIJA is an investigational treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. The resubmission addressed the two issues raised in the recent Refusal to File (“RTF”) letter and included all additional information requested by the FDA in that letter. The INBRIJA NDA is being submitted as a 505(b)(2) application. The FDA is expected to inform the Company within 74 days if the submission has been deemed complete and permits a full review. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item.
Item 9.01Financial Statements and Exhibits
(d) Exhibits
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Exhibit No. |
Description |
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99.1 |
Press Release dated December 7, 2017 |
ACORDA THERAPEUTICS INC ExhibitEX-99.1 2 acor-ex991_6.htm EX-99.1 acor-ex991_6.htm EXHIBIT 99.1 CONTACT: Felicia Vonella (914) 326-5146 fvonella@acorda.com FOR IMMEDIATE RELEASE Acorda Resubmits New Drug Application for INBRIJA™ (CVT-301,…To view the full exhibit click here
About Acorda Therapeutics,Inc. (NASDAQ:ACOR)
Acorda Therapeutics, Inc. is a biopharmaceutical company. The Company is engaged in the identification, development and commercialization of therapies that restore function and recovers the lives of people with neurological disorders. Its commercial products include Ampyra, Fampyra, Zanaflex Capsules and a generic version of the capsules, Zanaflex tablets and Qutenza. Its research and development programs include CVT-301, Dalfampridine, Plumiaz, Neuregulin Program, Remyelinating Antibodies Program, CVT-427 and Chondroitinase Program. Its Ampyra is an oral drug for the treatment to improve walking in patients with multiple sclerosis. Zanaflex Capsules and tablets are used as short-acting drugs for the management of spasticity. Qutenza is a dermal patch for the management of neuropathic pain associated with post-herpetic neuralgia. Its pipeline of neurological therapies addresses a range of disorders, including Parkinson’s disease, chronic post-stroke walking deficits and migraine.