NEW YORK: Glenmark Pharmaceuticals has received the final nod from the U.S. health regulator for a generic version of anti-bacterial drug Zyvox.
"Glenmark Pharmaceuticals Inc, USA, has been granted final approval by the U.S. 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 U.S. marketplace and 62 abbreviated new drug applications (ANDA) pending approval with USFDA.
Glenmark Pharmaceuticals was trading at Rs 938.60 on BSE, up 1.21 percent, at 1112 hours.
On December 22, 2015, Glenmark Pharma closed at Rs 938.05, up Rs 10.65, or 1.15 percent. The 52-week high of the share was Rs 1261.95 and the 52-week low was Rs 703.50.
The company's trailing 12-month (TTM) EPS was at Rs 52.77 per share as per the quarter ended September 2015. The stock's price-to-earnings (P/E) ratio was 17.78. The latest book value of the company is Rs 175.54 per share. At current value, the price-to-book value of the company is 5.34.
Also Read:
RCom, Aircel in Talks to Merge India Wireless Business
Thomas Cook India Partners With Essel Group Firm Itzcash
