FDA refuses Acorda NDA for Parkinson's drug candidate because of manufacturing issues

Fierce Pharma ------- With generics threatening its main money making med, and an investor threatening it independence, Acorda Therapeutics has been pinning its hopes on approval of a new Parkinson’s disease drug. But that is now in jeopardy because of questions the FDA has about its manufacturing readiness. The FDA delivered Acorda a Refusal to File (RTF) letter for Inbrija, a self-administered, inhaled formulation of levodopa for treating Parkinson’s disease, the Ardsley, New York-based company reported today, leading its shares to fall more than 25%. The company said the FDA has two issues with its NDA, saying there were questions about when its manufacturing site would be ready for a pre-approval inspection and over its drug master production records. Acorda said the FDA wanted some other info as well, but the FDA indicated that was not specific to the RTF. To learn more click on the picture below to read the article.