Generic Drug Approvals

Generic Drug Approvals. First-Time Generic Approvals. Mobic, Propecia, Zithromax

Generic Azithromycin Oral Suspension (Zithromax) for Indicated Infections


August 25th, 2007 by admin


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On July 5, the FDA approved first-time generic formulations for azithromycin 100-mg/5-mL and 200-mg/5-mL oral suspension (made by Pliva, Inc; brand name Zithromax, made by Pfizer, Inc).

Azithromycin for oral suspension may be taken with or without food. Pediatric indications include acute otitis media, acute bacterial sinusitis, community-acquired pneumonia (CAP), and pharyngitis/tonsillitis.

Adult indications include CAP; pharyngitis/tonsillitis; skin/skin structure infections; acute bacterial exacerbations of chronic obstructive pulmonary disease; acute bacterial sinusitis; genital ulcer disease in men; and nongonococcal and gonococcal urethritis and cervicitis.

Generic formulations were previously approved for azithromycin 500-mg/vial injection and 250-, 500-, and 600-mg tablets.

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