According to the company, 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 is now hoping to schedule a meeting with the FDA to review the comments in detail. The company said that it is currently unable to predict when or if Vadova might be available for commercial launch.
“We are disappointed with this development and we will work diligently with the FDA and the contract laboratory to provide the additional data required for approval as fast as prudently possible. 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,” commented Dr Larry Hsu, Impax’ president.