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Lupin gets USFDA approval for generic diabetes drug

Thursday, 10 April 2014 - 9:00am IST | Place: Mumbai | Agency: dna

Lupin Pharmaceuticals Inc (LPI), the US subsidiary of Indian drug maker Lupin Ltd, has received final approval from the United States Food and Drugs Administration (USFDA) to sell generic diabetes management drug Pioglitazone Tablets in the American market.

Lupin's first approval for fiscal 2015, the drug is a version of Takeda Pharmaceuticals USA Inc's Actos tablets. The drug maker said, LPI will soon commence marketing of its Pioglitazone Tablets USP, which will be made available in strengths of 15 mg, 30 mg and 45 mg.

The company said, quoting IMS data for December 2013, that the Actos generic had annual sales of $236 million in the US market and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.

To date, Lupin has received 100 approvals from the US drug regulator and launched 17 products thre during the FY 2013-2014 and. As of December, 2013 the company's cumulative Abbreviated New Drug Application (ANDA) filings with the USFDA stood at 186.

The drug maker produces and develops a wide range of branded and generic formulations and active pharmaceutical ingredients globally. A significant player in the cardiovascular, diabetology, asthma, pediatric, CNS, GI, anti-Infective and NSAID space it holds global leadership positions in the Anti-TB and cephalosporin segment.

For the third quarter ended on December 31, 2103, Lupin's consolidated net profit (year-on-year) increased 42% to Rs 476.13 crore on 21% growth in net sales to Rs 2,982.97 crore.

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