First-Time Generic Approvals: Proscar, Omnicef, Zaditor

Yael Waknine

June 20, 2006

June 20, 2005 — The U.S. Food and Drug Administration (FDA) has approved first-time generic formulations of finasteride 5-mg tablets for the treatment of benign prostatic hyperplasia in men with an enlarged prostate; cefdinir 125-mg/5-mL oral suspension for the treatment of respiratory and skin infections; and ketotifen fumarate 0.025% ophthalmic solution for the temporary prevention of ocular itching associated with allergic conjunctivitis.

Generic Finasteride 5-mg Tablets (Proscar) for BPH

On June 19, the FDA approved a first-time generic formulation for finasteride 5-mg tablets (made by Teva Pharmaceutical Industries, Ltd; brand name Proscar, made by Merck and Company). According to a company news release, product shipments will begin immediately.

Finasteride tablets are indicated for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men with an enlarged prostate, to improve symptoms; reduce the risk for acute urinary retention; and decrease the risk for surgery such as transurethral resection of the prostate (TURP) and prostatectomy.

They are also indicated for use in combination with doxazosin therapy to reduce the risk for symptomatic progression of BPH.

Generic Cefdinir 125-mg/5-mL Oral Solution (Omnicef) for Respiratory and Skin Infections

On May 31, the FDA approved a first-time generic formulation for cefdinir 125-mg/5-mL oral suspension (made by Lupin Pharmaceuticals, Inc; brand name Omnicef, made by Abbott Laboratories, Inc).

Cefdinir 300-mg capsules (also available in generic form) and 125- and 250-mg/5-mL oral suspension are indicated for the treatment of mild to moderate infections caused by susceptible strains of designated microorganisms.

In adults, the third-generation cephalosporin is indicated for the treatment of community-acquired pneumonia; acute exacerbation of chronic bronchitis; acute maxillary sinusitis; pharyngitis/tonsillitis; and uncomplicated skin/skin structure infections.

Pediatric indications include acute bacterial otitis media; pharyngitis/tonsillitis, and uncomplicated skin/skin structure infections.

Generic Ketotifen Fumarate 0.025% Ophthalmic Solution (Zaditor) for Allergic Conjunctivitis

On May 9, the FDA approved a first-time generic formulation for ketotifen fumarate 0.025% ophthalmic solution (made by Apotex, Inc; brand name Zaditor, made by CIBA Vision [a Novartis company]).

Ketotifen fumarate ophthalmic solution is indicated for the temporary prevention of ocular itching associated with allergic conjunctivitis.

Reviewed by Gary D. Vogin, MD

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