Impax’s Parkinson’s Drug NDA Rejected Due to Manufacturing Issues
The FDA’s rejection of Impax Pharmaceuticals’ extended-release capsule Rytary for the treatment of idiopathic Parkinson’s disease points to continuing problems at a California manufacturing site.
On Monday, Impax announced it had received a complete response letter requiring “a satisfactory re-inspection of the company’s Hayward facility … due to the facility’s involvement in the development” of the drug. The news is only the most recent in a long list of issues between Impax and the FDA over the California plant.
In May 2011, the FDA issued a warning letter for deviations in sampling and testing of in-process materials and drug products at the Hayward facility that resulted in a recall of fenofibrate capsules.
Under the latest PDUFA, the FDA has five new criteria for choosing facilities to inspect – are you more likely to be inspected next? Will you be ready?
PDUFA V: A Drugmaker’s Guide to Provisions in the New Law is available as a pdf or hard copy and everyone at your company will be able to share in the vast wealth of knowledge we have collected for you. Don’t waste countless hours researching all the provisions in PDUFA, order your copy today!