Aurobindo Pharma gets USFDA approval for diabetes drug

Aurobindo Pharma said it has received final approval from the US health regulator to manufacture and market Metformin Hydrochloride tablets used for treating diabetes.

“The company has received final approval from the United States Food and Drug Administration (USFDA) to manufacture and market Metformin Hydrochloride extended release tablets USP,” Aurobindo Pharma said in a statement.

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The approval is for tablets in the strengths of 500 mg and 750 mg and the product is ready for launch, it added. Metformin Hydrochloride extended release tablets USP, 500 mg and 750 mg, are generic equivalent to Bristol Myers Squibb’s Glucophage XR extended release tablets in the same strengths.

The tablets are indicated to control glucose levels in patients with type II diabetes. Aurobindo Pharma currently has a total of 153 abbreviated new drug application (ANDA) approvals from USFDA, the company said.

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Shares of Aurobindo Pharma were trading at Rs 108.85 apiece in the afternoon trade on the BSE up 0.51 percent from its previous close.

PTI