Future unclear for Impax Parkinson’s drug
This article was originally published in Pharmaceutical Approvals Monthly
Executive SummaryImpax Laboratories is evaluating options for its Parkinson's disease candidate Vadova (carbidopa/levodopa) after receiving its second "not approvable" letter from FDA, the firm announces Jan. 30. According to the company, "FDA's action is 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." Bristol-Myers Squibb markets a controlled-release carbidopa/levodopa as Sinemet CR. "We will continue to pursue discussions with FDA concerning this decision and we are evaluating all options for the product," Impax CEO Larry Hsu said. The first "not approvable" letter was issued over concerns with clinical pharmacology and chemistry, manufacturing and controls, which Impax said were successfully resolved and were not cited in the second letter...
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