HYDERBAD: Aurobindo Pharma has received approval from the U.S. health regulator to market generic Entecavir tablets, used to treat hepatitis B, in the American market.
The company has received final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Entecavir tablets in strengths of 0.5mg and 1mg, Aurobindo Pharma said in a statement.
The Hyderabad-based firm's approved abbreviated new drug application (ANDA) is therapeutically equivalent to Bristol-Myers Squibb's Baraclude tablets.
Entecavir tablets are indicated for treatment of chronic hepatitis B virus infection of the liver.
According to IMS data, the product has an estimated market size of USD 294 million for the 12 months ending June 2015.
"This is the 44th ANDA to be approved out of Unit VII formulation facility in Hyderabad for manufacturing oral non-antibiotic products," the company said.
The company has now a total of 209 ANDA approvals from the USFDA. Aurobindo Pharma shares were trading at Rs 744 apiece on BSE, up 2.90 percent from previous close.
Aurobindo Pharm stock price
On August 27, 2015, Aurobindo Pharma closed at Rs 743.90, up Rs 20.90, or 2.89 percent. The 52-week high of the share was Rs 1540.55 and the 52-week low was Rs 382.50.
The company's trailing 12-month (TTM) EPS was at Rs 26.18 per share as per the quarter ended June 2015. The stock's price-to-earnings (P/E) ratio was 28.41. The latest book value of the company is Rs 94.68 per share. At current value, the price-to-book value of the company is 7.86.
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