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Acorda Therapeutics, Inc.
Acorda Therapeutics Announces Eligibility of Fampridine-SR for Centralized Review in Europe
June 26th, 2009
Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced that, in response to its eligibility application to the European Medicines Agency (EMEA) for Fampridine-SR, the EMEA has notified the Company that Fampridine-SR is eligible to be submitted for a Marketing Authorization Application (MAA) via the Agency's Centralized Procedure. The Centralized Procedure provides for a single, coordinated review that is conducted by the EMEA on behalf of all European Union (EU) member states. The EMEA also designated Fampridine-SR as a New Active Substance (NAS); if approved, compounds designated as an NAS receive a 10-year market exclusivity period in EU member states. ...
Source: Health Business Week (2009-06-26)
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