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Ranbaxy gets US FDA approval for diabetic drug

Our Bureau

Mumbai , June 22

DRUG company Ranbaxy Laboratories Ltd said on Tuesday that its anti-diabetic drug has got the final approval from regulatory authorities in the US.

The US Food and Drug Administration (US FDA) has given Ranbaxy the green signal to market Metformin Hydrochloride Extended-release Tablets, 500 mg, said a company release.

The approval came after Barr Laboratories Inc, a wholly-owned subsidiary of Barr Pharmaceuticals Inc, selectively waived its rights to exclusivity in favour of Ranbaxy.

Bristol Myers Squibb (BMS) is the original patent holder of the anti-diabetic drug that it sells under the brandname `Glucophage XR Tablets.'

Regulatory authorities in the US have found Ranbaxy's version of the drug to be bio-equivalent to BMS's drug, besides having the same therapeutic effect.

Total sales for the Metformin Extended-release formulation is $363 million, industry sources said.

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