NEW DELHI: Glenmark Pharmaceuticals has received the final nod from the US health regulator for a generic version of anti-bacterial drug Zyvox.
“Glenmark Pharmaceuticals Inc, USA, has been granted final approval by the US Food & Drug Administration (USFDA) for the Linezolid tablets, 600 mg,” Glenmark Pharmaceuticals said in a statement.
The product is the therapeutic equivalent of Zyvox tablets, 600 mg of Pharmacia and Upjohn Company, a subsidiary of Pfizer, it added.
According to IMS Health sales data for the 12 months to October 2015, Zyvox tablets, 600 mg, achieved annual sales of around USD 447.6 million, Glenmark said.
Zyvox is an anti-bacterial drug marked for adults and children for treatment of infections such as pneumonia, complicated skin and skin structure infections, including diabetic foot infections.
With today’s approval, the company’s current portfolio consists of 104 products authorised for distribution in the US marketplace and 62 abbreviated new drug applications (ANDA) pending approval with USFDA.