Acorda Therapeutics,Inc. (NASDAQ:ACOR) Files An 8-K Other EventsItem 8.01Other Events
On August 29, 2017, Acorda Therapeutics, Inc. (the “Company”) issued a press release announcing 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 with the FDA, to respond to the issues, which it believes are addressable, and to seek clarification of what additional information will be required. The FDA has not requested or recommended additional clinical efficacy or safety studies. 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 August 29, 2017 |
ACORDA THERAPEUTICS INC ExhibitEX-99.1 2 acor-ex991_15.htm PRESS RELEASE acor-ex991_15.htm EXHIBIT 99.1 CONTACT: Investors/Analysts: Media: Felicia Vonella Tierney Saccavino Investor Relations Corporate Communications (914) 326-5146 (914) 326-5104 fvonella@acorda.com tsaccavino@acorda.com FOR IMMEDIATE RELEASE Acorda Receives Refusal to File Letter from FDA 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.