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Pfizer "terminates" Lipitor OTC switch in US

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Pfizer "terminates" Lipitor OTC switch in US

Pfizer has "terminated" its programme to switch the cholesterol-lowering drug Lipitor (atorvastatin) from prescription-to-OTC status in the US, according to a report in OTCToolbox. Chief executive officer Ian Read said the company "continues to evaluate other products for potential prescription-to-OTC switches".

The company said its actual-use trial for Lipitor in a simulated OTC setting, which was completed in December 2014, had failed to meet the primary objective.

Pfizer explained that the study had not demonstrated "patient compliance with the direction to check their low-density lipoprotein cholesterol (LDL-C) level and, after checking their LDL-C level, take appropriate action based on their test results".

Previous applications to switch statins in the US have all been rejected by the FDA.

Click here for the full report.

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