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News Breaks
June 26, 2014
06:03 EDTACOR, ACTAcorda Therapeutics notified of Actavis' ANDA filing for generic Ampyra
Acorda Therapeutics (ACOR) received a Paragraph IV Certification Notice Letter advising that Actavis Laboratories (ACT) submitted an Abbreviated New Drug Application - ANDA - to the FDA requesting permission to manufacture and market a generic version of Ampyra Extended Release Tablets, 10 mg. Acorda is reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Actavis Laboratories in order to trigger a statutory stay period under the Hatch-Waxman Act. This would restrict the FDA from approving an ANDA until July 2017. Ampyra is currently protected by five patents listed in the FDAs Approved Drugs Product List. Acorda intends to vigorously defend its intellectual property rights.
News For ACOR;ACT From The Last 14 Days
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July 22, 2014
16:09 EDTACTActavis initiated with a Buy at Deutsche Bank
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July 21, 2014
16:36 EDTACTActavis and Medicines360 announce FDA acceptance of Levosert NDA
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July 17, 2014
15:42 EDTACTDepomed says Actavis preliminarily enjoined from marketing generic Gralise
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11:07 EDTACORAcorda sues Mylan over plans to duplicate Ampyra MS drug, Bloomberg says
July 16, 2014
11:28 EDTACTLeon Cooperman gives 12 stock picks at CNBC conference
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11:16 EDTACTCooperman lists Actavis, Citigroup, KKR among top-picks, CNBC says
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09:12 EDTACTLeerink healthcare analyst holds an analyst/industry conference call
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July 11, 2014
16:31 EDTACTActavis confirms generic Diclegis patent challenge
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July 9, 2014
06:49 EDTACTGeneric drug prices have risen significantly, NY Times says
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06:45 EDTACORAcorda Therapeutics to initiate Phase 3 clinical trial for dalfampridine
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July 8, 2014
16:11 EDTACTActavis files ANDA for Dalfampridine tablets
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