Alembic Pharmaceuticals receives USFDA final approval for Azithromycin Tablets

Alembic Pharmaceuticals announced it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Azithromycin Tablets USP, 600 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Zithromax Tablets, 600 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; community acquired pneumonia in adults and pharyngitis/tonsillitis in adults.

Azithromycin Tablets USP, 600 mg have an estimated market size of US$ 2 million for twelve months ending September 2019 according to IQVIA.

 

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