First-Time Generic Approvals: Triostat, Rocephin, Allegra

Yael Waknine

September 23, 2005

Sept. 23, 2005 — The U.S. Food and Drug Administration (FDA) has approved first-time generic formulations of 10 µg (base)/mL liothyronine sodium injection in 1-mL vials for the treatment of myxedema coma/precoma; 1 g/50 mL and 2 g/50 mL ceftriaxone injection packaged in galaxy single-dose plastic containers for the treatment of infections caused by susceptible micro-organisms and for prophylaxis of postsurgical infections; and 30, 60, and 180 mg fexofenadine HCl tablets for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria in patients aged six years and older.

Generic 10 µg/mL Liothyronine Sodium Injection (Triostat) for Myxedema Coma/Precoma

On Aug. 17, the FDA approved a first-time generic formulation of 10 µg [base]/mL liothyronine sodium injection in 1-mL vials (made by Pharmaforce, Inc.; brand name Triostat, made by Jones Pharma, Inc.)

Liothyronine sodium injection is indicated for the treatment of myxedema coma/precoma. It can be used in patients allergic to desiccated thyroid or thyroid extract derived from pork or beef.

Generic 1 g and 2 g/50 mL Ceftriaxone Injection (Rocephin) for Infections, Surgical Prophylaxis

On Aug. 23, the FDA approved first-time generic formulations of 1 g/50 mL and 2 g/50 mL ceftriaxone injection packaged in galaxy single-dose plastic containers (made by Baxter Healthcare Corp.; brand name Rocephin, made by Hoffman-LaRoche).

Ceftriaxone injection is indicated for the treatment of infections caused by susceptible micro-organisms, including skin and skin structure infections, acute bacterial otitis media, lower respiratory tract infections, urinary tract infections, uncomplicated gonorrhea, pelvic inflammatory disease, bacterial septicemia, bone and joint infections, intra-abdominal infections, and meningitis. It is also indicated for the prophylaxis of postsurgical infections.

Generic 30, 60, and 180 mg Fexofenadine Tablets (Allegra) for Seasonal Allergic Rhinitis, Chronic Idiopathic Urticaria

On Aug. 31, the FDA approved first-time generic formulations of 30, 60, and 180 mg fexofenadine HCl tablets (made by Barr Laboratories, Inc.; brand name Allegra, made by Aventis Pharmaceuticals, Inc.).

Fexofenadine tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children aged six years and older. Symptoms treated effectively in clinical studies included sneezing, rhinorrhea, itchy nose/palate/throat, and itchy/watery/red eyes.

Fexofenadine is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children aged six years and older. In clinical studies, fexofenadine significantly reduced pruritus and number of wheals.

Reviewed by Gary D. Vogin, MD

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