FDA says IMPAX' Vadova not approvabale

IMPAX Laboratories says it has received a non-approvable letter from the US Food and Drug Administration concerning its new drug application and subsequent submissions for Vadova (carbidopa/levodopa extended-release) tablets.

The FDA's action was primarily based on unresolved issues relating to product nomenclature and its belief of a likelihood of medication errors resulting from confusion of Vadova with other marketed forms of carbidopa/levodopa. The NDA, which was originally filed in April 2005, was deemed non-approvable in March 2006. IMPAX subsequently filed responses addressing the FDA's earlier concerns, which included clinical pharmacology and chemistry, manufacturing and control components. These concerns were not cited in the most recent non-approvable letter.

"We are very disappointed with the receipt of this letter, and we continue to believe that Vadova represents a significant improvement in the choices available to patients in the treatment of the symptoms of Parkinson's disease," said Larry Hsu, chief executive of IMPAX, adding: "we will continue to pursue discussions with the FDA concerning this decision and we are evaluating all options for the product."