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Ampyra Approval History

FDA Approved: Yes (First approved January 22, 2010)
Brand name: Ampyra
Generic name: dalfampridine
Dosage form: Extended Release Tablets
Previous Name: Fampridine-SR
Company: Acorda Therapeutics, Inc.
Treatment for: Multiple Sclerosis

Ampyra (dalfampridine) is an oral potassium channel blocker indicated to improve walking ability in people with multiple sclerosis.

Development History and FDA Approval Process for Ampyra

DateArticle
Jan 22, 2010Approval FDA Approves Ampyra to Improve Walking in Adults with Multiple Sclerosis
Oct 22, 2009Acorda Therapeutics Announces Extension of Fampridine-SR PDUFA Goal Date to January 22, 2010
Oct 14, 2009Acorda Therapeutics Announces Positive Vote by FDA Advisory Committee for Fampridine-SR
Aug 25, 2009Acorda Therapeutics Reports Date of FDA Advisory Committee Review of Fampridine-SR for Improvement of Walking Ability in People with MS
May  6, 2009Acorda Therapeutics Announces FDA Acceptance of Fampridine-SR New Drug Application for Filing
Apr 23, 2009Acorda Therapeutics Resubmits New Drug Application for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis
Mar 31, 2009Acorda Therapeutics Receives Refuse to File Letter from FDA on Fampridine-SR NDA
Feb  2, 2009Acorda Therapeutics Submits NDA for Fampridine-SR for Improvement of Walking Ability in People with Multiple Sclerosis

Further information

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