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USFDA issues advisory against simvastatin 80 mg

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Press Trust of India New Delhi

The US health regulator issued an advisory on the usage of drugs having cholesterol-lowering molecule simvastatin in 80 mg strength, citing risk of muscle injury that could have some impact on the revenues of Indian generic firms, including Ranbaxy and Dr Reddy's.

"The US Food and Drug Administration [USFDA] is recommending that the use of drugs containing 80 mg of simvastatin—the highest approved dose of the popular cholesterol-lowering statin—be sharply curtailed because of the risk of muscle injury," USFDA said in a statement posted on its website.

According to USFDA, the 80 mg dosage should only be used by patients who have been taking it for 12 months or longer without any ill effect.

 

"Our overall goal is to get doctors to not start patients on 80 mg of simvastatin," USFDA's Division of Metabolism and Endocrinology Products Deputy Director Eric Colman said.

Industry analysts pointed out that the development could have some impact on companies like Dr Reddy's Laboratories and Ranbaxy Laboratories, which market Simvastatin in 80 mg strength in the US.

"This is certainly an issue which generic Indian players manufacturing 80 mg dosage of Simvastatin will need to engage in effective dialogue with USFDA to resolve the issue," KPMG Executive Director Hitesh Gajaria said.

Comments from Ranbaxy and Dr Reddy's could not be obtained as queries remained unanswered.

Another analyst, who wished not to be identified, said the impact will not be significant on the sales of the domestic drug companies as the US market for the drug is already divided between 12 generic players out of which 6 are Indian firms.

Simvastatin is sold under the brand-name Zocor by American firm Merck and is used to reduce the amount of bad cholesterol in blood.

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First Published: Jun 10 2011 | 8:47 PM IST

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