Aurobindo Pharma receives USFDA nod for anti-infective injection

Aurobindo Pharma to produce and mkt its Linezolid injection.

The Dollar Business Bureau

Aurobindo Pharma on Monday announced that it has received the go-ahead from the US-based health regulator USFDA to manufacture and market its anti-infective Linezolid injection in the American market. 

"The company has received final approval from the United States Food & Drug Administration (USFDA) to manufacture and market Linezolid injection, 600 mg/300 mL (2 mg/mL)," Aurobindo Pharma said in a statement.

The company plans to launch the product during the second quarter of the current financial year. It has the generic version of Pharmacia & Upjohn Company's Zyvox injection in the same strength.  

"The approved product has an estimated market size of $87 million for the twelve months ending June 2016 according to IMS," it said.

This latest approval is Aurobindo Pharma’s 36th abbreviated new drug application (ANDA), which includes two tentative approvals, to be approved from its IV formulation facility in Hyderabad, the company added.

"Aurobindo now has a total of 275 ANDA approvals (235 final approvals including 13 from Aurolife Pharma LLC and 40 tentative approvals) from USFDA, the company said.

Meanwhile, New Delhi-based Glenmark Pharmaceuticals Ltd., too, has received final approval from the US health regulator for Triamcinolone acetonide cream used for lessening redness, itching and swelling on skin.

 “Glenmark Pharmaceuticals Inc has been granted final approval by the United States Food and Drug Administration for Triamcinolone acetonide cream USP, 0.1 per cent,” Glenmark said in a statement.

The Dollar Business Bureau - Aug 08, 2016 12:00 IST