First-Time Generic Approvals: Zithromax, Cefzil, Zonegran

Yael Waknine

January 27, 2006

Jan. 27, 2006 -- The US Food and Drug Administration (FDA) has approved first-time generic formulations of azithromycin 500-mg/vial intravenous infusion for the treatment of community-acquired pneumonia and for pelvic inflammatory disease caused by susceptible strains of designated microorganisms; cefprozil 125-mg/5-mL and 250-mg/5-mL suspension for respiratory tract and skin/skin structure infections; and zonisamide 25-, 50-, and 100-mg capsules for adjunctive treatment of partial seizures in epileptic adults.

Generic Azithromycin Injection (Zithromax) for CAP and PID

On December 13, the FDA approved a first-time generic formulation for azithromycin 500-mg/vial (made by American Pharmaceutical Partners, Inc; brand name Zithromax, made by Pfizer, Inc).

Azithromycin intravenous infusion is indicated for the treatment of community-acquired pneumonia (CAP) and pelvic inflammatory disease (PID) caused by susceptible strains of designated microorganisms.

Generic Cefprozil Suspension (Cefzil) for Respiratory Tract and Skin/Skin Structure Infections

On December 8, the FDA approved first-time generic formulations for cefprozil 125-mg/5-mL and 250-mg/5-mL suspension (made by Teva Pharmaceuticals USA; brand name Cefzil, made by Bristol-Myers Squibb Company).

Cefprozil suspension is indicated for the treatment of pharyngitis/tonsillitis, otitis media, acute sinusitis, secondary bacterial infection of acute bronchitis, acute bacterial exacerbation of acute bronchitis, and uncomplicated skin/skin structure infections caused by susceptible strains of designated microorganisms.

Generic Zonisamide Capsules (Zonegran) for Adjunctive Treatment of Partial Seizures

On December 22, the FDA approved first-time generic formulations for zonisamide 25-, 50-, and 100-mg capsules (made by Alphapharm Pty Ltd, Teva Pharmaceuticals USA, Apotex Inc, Sandoz Inc, Barr Laboratories Inc, Roxane Laboratories Inc, Dr. Reddy's Laboratories Limited, and Wockhardt Limited; brand name Zonegran, made by Dainippon Pharmaceutical USA Corp).

Zonisamide is indicated as adjunctive therapy for the treatment of partial seizures in epileptic adults.

Reviewed by Gary D. Vogin, MD

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