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Our Bureau

Mumbai, July 31

GlaxoSmithKline’s (GSK) diabetes medicine, Avandia, sold in India under the Windia brandname, will continue to be available in the country, the company has said.

The affirmation came in the wake of a recommendation by an advisory panel of the US Food and Drug Administration (USFDA) that Avandia should not be pulled out of the market, despite a potential heart risk.

Rosiglitazone is sold by GSK as Avandia and the drug has been under the regulatory scanner over the last few months following an article in the New England Journal of Medicine linking Avandia to a potential heart risk.

Subsequently, the issue has swung back and forth between the company and regulatory agencies.

All eyes are now on the US FDA on whether it would indeed recommend a black box warning on the Avandia pack.

Dr Sadhna Joglekar, Vice-President (Medical Affairs and Clinical Research), GSK, told Business Line that the company was watching developments in the US regarding safety labels.

“We will do here as required by the Indian regulatory authorities,” she said, adding that the company has been in touch with the regulatory Drug Controller-General of India.

GSK has been selling Windia in India over the last 18 months. Over 10 generic versions of the drug are also sold in India, and the companies behind these too will be watching the signals emerging from different regulators.

More Stories on : Health | Announcements | Glaxosmithkline Pharmaceuticals Ltd | Pharmaceuticals

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