August 4th, 2011
Pfizer Wants to Market OTC Atorvastatin (Lipitor)
Pfizer will attempt to gain FDA approval to sell atorvastatin (Lipitor) over-the-counter, according to a report by Peter Loftus in the Wall Street Journal. In the past, the FDA has turned down requests to market other statins over-the-counter. Lipitor is scheduled to go off patent in November, well before an OTC version of the drug could become available.
Many believe Pfizer faces a long upward climb with no assurance of success. But Loftus quotes an FDA spokesperson who states that “the agency is open to discussing OTC statins, as long as companies are ready to demonstrate that consumers will make the right decisions.”
The chair of an FDA advisory panel in 2008 that rejected OTC lovastatin explained that panel’s reasoning in an article in the New England Journal of Medicine.