Bristol Pravachol OTC Label Studies, Redefined Population Urged By Cmte.
Bristol-Myers Squibb's Pravachol (pravastatin) 10 mg is an attractive candidate for OTC status, but the company should first conduct additional label comprehension studies and better define the target population for the cholesterol agent, FDA advisory committee members suggested July 14.
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Bristol-Myers Squibb may need to better demonstrate consumers' ability to make self-selection choices based on appropriate cholesterol levels in order to convince FDA that an OTC version of Pravachol is approvable.
The drug interaction profile of Bristol-Myers Squibb's Pravachol may make the cholesterol-lowering agent a more attractive OTC switch candidate than Merck's Mevacor, members of the statin OTC switch advisory committee suggested.
The reason individuals switch from taking prescription cholesterol-lowering agents to OTC Pravachol (pravastatin) in actual use studies should be the subject of additional research, FDA advisory committee members suggested to Bristol-Myers Squibb July 14.