Impax Laboratories says the FDA has formally turned thumb's down on Vadova, its experimental Parkinson's drug. In a release, the company said that the nonapprovable letter stated that the agency was rejecting the drug "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."
"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, Ph.D., president and chief executive officer of IMPAX Laboratories. "We will continue to pursue discussions with the FDA concerning this decision and we are evaluating all options for the product."
- read the release for more