Alembic pharmaceuticals receives final approval from USFDA for its Clarithromycin tablets

Alembic pharmaceuticals receives final approval from USFDA for its Clarithromycin tablets

By, Admin 2 February 2022

Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in acute bacterial exacerbation. Alembic Pharmaceuticals Limited received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) of Clarithromycin tablets USP, 250 mg and 500 mg. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) Biaxin Filmtab Tablets from AbbVie. Clarithromycin tablets are a macrolide antimicrobial indicated for mild to moderate infections caused by designated, susceptible bacteria in acute bacterial exacerbation. The bacterial infection can be due to 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. According to IQVIA, Clarithromycin tablets USP, 250 mg and 500 mg have an estimated market size of US$ 11 million for twelve months ending in September 2021. Alembic has till now received 20 approvals (14 final and 6 tentative approvals) and a cumulative total of 159 ANDA approvals (137 final approvals and 22 tentative approvals) from USFDA

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