The US Food and Drug Administration (USFDA), health regulator of the US market, has issued a warning that the 80 mg version of cholesterol-lowering drug Simvastatin should not be prescribed to new patients as the high-dose version has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use. Indian pharmaceutical firms like Ranbaxy, Dr Reddy’s Labs, Lupin and Zydus Cadila are selling simvastatin in the United States.
Simvastatin is used to lower the amount of low-density lipoprotein (LDL) or the ‘bad’ cholesterol to reduce the risk of heart attacks and strokes.
“The agency has recommend use of Simvastatin 80 mg only in patients who have been taking this dose for 12 months or more and have not experienced any muscle toxicity and not prescribed to new patients,” US FDA said in a statement on Wednesday. There are also new contraindications and dose limitations when simvastatin is taken with certain other medications, it said.
According to analysts, there would be no major impact on generic players, as the margin remains less due to the presence of too many copycat versions.
The patented version of Simvastatin-Zocor, manufactured by Merck, was approved in 1991 and went off patent in 2006.
Since its patent expiry, all major generic players including Ranbaxy, Dr Reddy’s, Zydus Cadila and Lupin, launched copycat versions in the US market. Zydus Pharmaceuticals (USA) Inc, launched generic simvastatin in 2006. Lupin and Dr Reddy’s Labs received approval to sell simvastatin in the US in 2007.
A Lupin spokesperson said, “We do not have any significant presence in the simvastatin 80 mg category.” Shares of Lupin went down by 0.25 per cent to close at Rs 438 on the Bombay Stock Exchange today. E-mails sent to Ranbaxy, Zydus Cadila and Dr Reddy’s did not elicit any response.
The FDA said about 2.1 million patients were prescribed for simvastatin 80 mg last year. Simvastatin is the second most prescribed drug in the US with 94 million prescriptions dispensed in 2010, according to IMS Health.
