Alembic Pharma bags USFDA approval for Clarithromycin Tablets USP

1 Feb 2022 , 04:42 PM

Alembic Pharmaceuticals Ltd. announced that the company has received US Food & Drug Administration (USFDA) Final Approval for Clarithromycin Tablets USP, 250 mg and 500 mg.

The approved ANDA is characteristically equivalent to the reference listed drug product (RLD) Biaxin Filmtab Tablets, 250 mg. and 500 mg, of AbbVie Inc. (AbbVie). Clarithromycin Tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in acute bacterial exacerbation of chronic bronchitis in adults; acute maxillary sinusitis; community-acquired pneumonia; pharyngitis/tonsillitis; uncomplicated skin and skin structure infections; acute otitis media in pediatric patients; treatment and prophylaxis of disseminated Mycobacterial infections; Helicobacter pylori infection and duodenal ulcer disease in adults.

Clarithromycin Tablets USP, 250 mg, and 500 mg have an estimated market size of US$ 11 million for twelve months ending September 2021 according to IQVIA.

Alembic has so far received 20 approvals (14 final approvals and 6 tentative approvals) during the year, and a cumulative total of 159 ANDA approvals (137 final approvals arid 22 tentative approvals) from USFDA.