Shares of Impax Laboratories slid today on its announcement that the FDA had issued a non-approvable letter for its drug Vadova for treating Parkinson's. The drug developer said it was uncertain whether it would ever be able to make the drug commercially available. The letter cites several deficiencies in the application, including observations resulting from an FDA inspection of the contract laboratory employed by Impax to perform bioequivalence studies. Impax added that it was seeking a meeting with the FDA to determine what new data would be needed for approval.
"We followed the study design described in our Investigational New Drug application and we believe the results obtained not only present a valuable product for the patient but are within the regulatory requirements," said Impax president Dr. Larry Hsu.
- here's the release [1]
Links:
[1] http://biz.yahoo.com/bw/060307/20060307005627.html?.v=1