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news.Impax Laboratories has received a non-approvable letter from the FDA concerning its new drug application and subsequent submissions for Vadova tablets.
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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.
Larry Hsu, president and CEO of Impax Laboratories, said: “We believe that Vadova represents a significant improvement in the choices available to patients in the treatment of the symptoms of Parkinson’s disease and will continue to pursue discussions with the FDA concerning this decision and we are evaluating all options for the product.”