Alembic Pharma gets USFDA go-ahead for anti-bacterial drug

Drug firm Alembic Pharmaceuticals has received the US health regulator's nod for anti-bacterial Doxycycline capsules.

"The company has received approval from the United States Food and Drug Administration (USFDA) for its ANDA for Doxycycline capsules USP 75 mg and 100 mg," Alembic Pharmaceuticals said in a BSE filing today.

The approved Abbreviated New Drug Application (ANDA) is therapeutically equivalent to a reference listed drug product Monodox capsules, 75 mg and 100 mg of Aqua Pharmaceuticals.

Doxycycline capsules are used in treatment and prevention of infections that are proved or strongly suspected to be caused by bacteria.

According to IMS December 2016 data, Doxycycline capsules had an estimated market size of USD 30 million.
 

The company now has a total of 62 ANDA approvals from the USFDA.