The U.S. Food and Drug Administration approved Acorda Therapeutics, Inc.’s Inbrija for intermittent treatment of “off” episodes in people with Parkinson’s disease treated with carbidopa/levodopa. Off episodes, also known as off periods, are defined as the return of Parkinson’s symptoms that result from low levels of dopamine between doses of oral carbidopa/levodopa, the standard oral baseline Parkinson’s treatment.…
FDA Extends Acorda’s Inbrija NDA Review Period
Acorda Therapeutics, Inc. announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for its review of the New Drug Application (NDA) of Inbrija (levodopa inhalation powder) from October 5, 2018 to January 5, 2019. This extension is related to recent submissions Acorda made in response to requests from FDA…
U.S. District Court Invalidates Four Multiple Sclerosis Drug Patents
Patent Trials and Appeal Board Upholds Four Ampyra Patents
Acorda Therapeutics, Inc. announced that the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) upheld all four patents challenged via the inter partes review (IPR) process. U.S. Patent Nos. 8,663,685 (the ‘685 patent), 8,440,703 (the ‘703 patent), 8,354,437 (the ‘437 patent) and 8,007,826 (the ‘826 patent) apply to Ampyra (dalfampridine) Extended Release Tablets,…