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Pharma major Dr Reddy's Laboratories Ltd said the issue pertaining to its promotional material for fondaparinux sodium for injection, with the US Food and Drug Administration has been closed.
In a release, the Hyderabad-based company said certain concerns expressed by the US regulator were fully addressed.
“The Division of Professional Promotion, USFDA, informed Dr Reddy's Laboratories on January 24 that the matters are now considered closed,” the release said.
Last month, the USFDA sent a warning letter to Dr Reddy's stating that the healthcare professional product information Web site for fondaparinux ‘minimises the serious risks' associated with it.
Fondaparinux is indicated for the treatment of acute deep-vein thrombosis.
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