First-Time Generic Approvals: Dilaudid, Cefzil, Zithromax

Yael Waknine

December 30, 2005

Dec. 30, 2005 -- The U.S. Food and Drug Administration (FDA) has approved first-time generic formulations of hydromorphone HCl 2-, 4-, and 8-mg tablets for analgesic use; cefprozil 250- and 500-mg tablets for the treatment of mild to moderate upper/lower respiratory tract and uncomplicated skin/skin structure infections caused by designated strains of susceptible microorganisms; and azithromycin 250-, 500-, and 600-mg tablets for the treatment of indicated mild to moderate bacterial infections in adults and children.

Generic Hydromorphone HCl 2-, 4-, and 8-mg Tablets (Dilaudid) for Analgesia

On November 9, the FDA approved first-time generic formulations of hydromorphone HCl 2-, 4-, and 8-mg tablets (made by KV Pharmaceutical Company; brand name Dilaudid, made by Abbott Laboratories).

Hydromorphone tablets are indicated for the management of pain in patients where an opioid analgesic is appropriate.

Generic Cefprozil 250- and 500-mg Tablets (Cefzil) for Respiratory Tract and Skin/Skin Structure Infections

On Nov. 14, the FDA approved first-time generic formulations of cefprozil 250- and 500-mg tablets (made by Sandoz, Inc; brand name Cefzil, made by Bristol-Myers Squibb),

Cefprozil tablets are indicated for the treatment of mild to moderate pharyngitis/tonsillitis, otitis media, acute sinusitis, secondary bacterial infections of acute bronchitis, acute bacterial exacerbations of chronic bronchitis, and uncomplicated skin/skin structure infections caused by susceptible strains of microorganisms.

Generic Azithromycin 250-, 500-, and 600-mg Tablets (Zithromax) for Indicated Infections

On Nov. 14, the FDA approved first-time generic formulations of azithromycin 250-, 500-, and 600-mg tablets (made by Teva Pharmaceuticals USA and Sandoz, Inc; brand name Zithromax, made by Pfizer, Inc).

Azithromycin tablets are indicated for the treatment of adults with mild to moderate infections caused by susceptible strains of designated microorganisms.

Specific indications for the 250-and 500-mg in adults include acute bacterial exacerbations of chronic obstructive pulmonary disease, acute bacterial sinusitis, community-acquired pneumonia (CAP), pharyngitis/tonsillitis, uncomplicated skin/skin structure infections, urethritis, cervicitis, and genital ulcer disease (men only). The tablets may also be used to treat acute otitis media, CAP, and pharyngitis/tonsillitis in pediatric patients.

Azithromycin 600-mg tablets are indicated for the treatment of acute bacterial exacerbations of chronic obstructive pulmonary disease, CAP, pharyngitis/tonsillitis, uncomplicated skin/skin structure infections, and non-gonococcal urethritis/cervicitis. They are also indicated for the prophylaxis and treatment of disseminated Mycobacterium avium complex (MAC) disease.

Reviewed by Jacqueline A. Hart, MD

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