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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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August 1, 2014
17:02 EDTACTActavis files to sell 843,085 ordinary shares
The offering is related to shares that may be issued upon the exercise of stock options granted under certain equity plans of Forest Laboratories to former employees or former directors of Forest.
July 31, 2014
06:24 EDTACORAcorda Therapeutics backs FY14 R&D $60M-$70M
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06:24 EDTACORAcorda Therapeutics reports Q2 Ampyra revenue $87.4M
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06:23 EDTACORAcorda Therapeutics reports Q2 GAAP EPS 11c, consensus 15c
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July 23, 2014
10:02 EDTACTOn The Fly: Analyst Initiation Summary
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08:10 EDTACTDeutsche Bank hosts an analyst Specialty Pharma/Industry conference call
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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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