The FDA needs to see additional data from Merck before approving an OTC version of the drugmaker’s cholesterol-lowering drug Mevacor (lovastatin).
The agency requested the data along with revised labeling for the drug in a non-approvable letter sent to Merck late last week.
“We’re evaluating the conditions outlined in the agency’s response to determine a path forward for Mevacor OTC,” Merck VP, global OTC regulatory and scientific affairs, Edwin Hemwall said in a statement.
In December, an FDA advisory panel recommended against approval of cholesterol-lowering Mevacor without a prescription by a 10 to 2 vote.
The rejection of Mevacor OTC marks the third time a global drugmaker has failed to win FDA approval for the drug’s non-prescription status.
Merck has twice failed before to convince the FDA – once in 2000 and once in 2005 – that patients could safely use Mevacor without a doctor’s prescription.
Mevacor lost US patent protection in 2001, with Merck and prospective marketing partner Johnson & Johnson trying to secure OTC status in the years to follow.
The UK became the first nation to approve an OTC statin in 2004, allowing the sale of a 10 mg version of simvastatin, which is marketed as Zocor Heart-Pro by Merck.
