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
Medscape Medical News © 2006 Medscape
Cite this: Yael Waknine. First-Time Generic Approvals: Zithromax, Cefzil, Zonegran - Medscape - Jan 27, 2006.