FDA approves Acorda's Inbrija for Parkinson's

Acorda Therapeutics Inc. (NASDAQ:ACOR) said FDA approved its Inbrija levodopa inhalation powder to treat "off" periods in Parkinson's disease patients receiving carbidopa/levodopa. The approval comes after multiple delays and gives Acorda a new product to bring to market following the arrival of generic competition for its multiple sclerosis drug Ampyra dalfampridine.

FDA approved Inbrija ahead of its Jan. 5 PDUFA date, although the drug's review was extended from its original Oct. 5 action date to permit the agency to examine additional CMC information that constituted a major amendment to its NDA. Acorda resubmitted the application in late 2017 after receiving a refusal to file letter from FDA in August of that year...