Alembic Pharma gets USFDA’s nod for Azithromycin Tablets

29 Jan 2020 Evaluate

Alembic Pharmaceuticals has received final approvals from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Applications (ANDAs) Azithromycin Tablets USP, 250 mg and 500 mg. The approved ANDAs are therapeutically equivalent to the reference listed drug products (RLDs), Zithromax Tablets, 250 mg and 500 mg, of Pfizer, Inc. (Pfizer).

Azithromycin Tablet is a macrolide antibacterial drug indicated for mild to moderate infections caused by designated, susceptible bacteria in acute bacterial exacerbations of chronic bronchitis in adults; acute bacterial sinusitis in adults; uncomplicated skin and skin structure infections in adults; urethritis and cervicitis in adults; genital ulcer disease in men; acute otitis media in pediatric patients; community-acquired pneumonia in adults and pediatric patients; and pharyngitis/tonsillitis in adults and pediatric patients.

Azithromycin Tablets USP, 250 mg and 500 mg have an estimated market size of $129 million for twelve months ending September 2019 according to IQVIA. Alembic has a cumulative total of 117 ANDA approvals (105 final approvals and 12 tentative approvals) from USFDA.

Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.

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