Pharma major Dr Reddy's Laboratories Ltd is redesigning the product Web site of fondaparinux sodium solution following a directive from the US Food and Drug Administration.

The Hyderabad-based company launched the limited competition product fondaparinex sodium injection in the US market in the second quarter of the current financial year.

FDA warning

The US regulator had sent a warning letter last month to Dr Reddy's stating that the healthcare professional product information “minimises the serious risks'' associated with fondaparinux, indicated for the treatment of acute deep-vein thrombosis.

When contacted, a functionary of Dr Reddy's said the Web site did have the warning, which is generally called ‘Black Box Warning' at the bottom of the portal.

“However, following directions from the USFDA, we are redesigning the portal to make Black Box warning more prominent,” he said.

The company would also intimate the regulator about the compliance to its letter soon, he added.

Dr Reddy's is manufacturing fondaparinux under licence using a patented process developed by Alchemia.

(This article was published on January 26, 2012)
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