Alembic gets USFDA approval to market Clarithromycin tablets in America

Alembic Pharmaceuticals on Tuesday said it has received approval from the US health regulator to market Clarithromycin tablets, used to treat mild to moderate infections, in the American market. The company has received the final approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Clarithromycin tablets in strengths of 250 mg and 500 mg, the drug firm said in a regulatory filing.

Alembic's product is therapeutically equivalent to AbbVie Inc's Biaxin Filmtab Tablets, which is antimicrobial indicated to treat mild to moderate infections caused by designated, susceptible bacteria.

According to IQVIA, Clarithromycin Tablets have an estimated market size of USD 11 million for 12 months ending September 2021.


The drug firm said it has so far received 159 ANDA approvals from the USFDA.