Alembic Pharmaceuticals receives USFDA approval for Clarithromycin Tablets

1 Feb 2022 , 10:52 AM

Alembic Pharmaceuticals (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Clarithromycin Tablets USP, 250 mg and 500 mg.

The approved ANDA is therapeutically 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 paediatric 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.

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