Aurobindo Pharma gets USFDA nod for hepatitis B drug
New Delhi, Aug 27: Aurobindo Pharma has received approval from the US health regulator to market generic Entecavir tablets, used to treat hepatitis B, in the American market.
The company has received final approval from the US 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.
The company has received final approval from the US 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.
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