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Tuesday 29 January 2008
FDA Rejects OTC Mevacor (Pharm Aid)
In the blog, the author writes about the not-approvable letter for Merck’s OTC version of the statin Mevacor. The FDA had been reviewing the application for the drug since 1999.
Before the agency will approve the Mevcor application, it wants more safety and enhanced product labeling. “In light of the recent brouhaha over statins and Vytorin, the FDA decision was certainly expected,” the author notes.
The agency’s actions demonstrate that the move toward harmonization of drug standards between the U.S. and the European Union has not materialized. “As evidence, back in May 2004, the UK approved Zocor (simvastatin) for OTC use. The move of statins to OTC was beneficial to the UK budget where the [National Health Service] has been able to shift some of the cost burden over to consumers.
“But status quo in the [U.S],” the author writes.