First-Time Generic Approvals: Nydrazid, Aclovate, Allegra

Yael Waknine

August 03, 2005

Aug. 3, 2005 — The U.S. Food and Drug Administration (FDA) has approved first-time generic formulations of isoniazid 100-mg/mL injection, U.S. Pharmacopeia, in 10-mL multiple-dose vials for the prophylaxis and treatment of tuberculosis; aclometasone dipropionate 0.05% cream, U.S. Pharmacopeia, for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged one year and older; and fexofenadine HCl 60-mg capsules for the relief of symptoms of seasonal allergic rhinitis and the treatment of chronic idiopathic urticaria in patients aged six years and older.

Generic Isoniazid Injection (Nydrazid) for Prophylaxis and Treatment of TB

On July 5, the FDA approved a first-time generic formulation of isoniazid 100-mg/mL injection, U.S. Pharmacopeia, in 10-mL multiple-dose vials (made by Sabex 2002, Inc.; brand name Nydrazid, made by Sandoz Pharmaceuticals, a Novartis company).

Isoniazid intramuscular injection is indicated for use in the prophylaxis and treatment of tuberculosis.

Generic Aclometasone Dipropionate Cream (Aclovate) for Rash Relief

On July 12, the FDA approved a first-time generic formulation of aclometasone dipropionate 0.05% cream, U.S. Pharmacopeia, made by Altana, Inc.; brand name Aclovate, made by GlaxoSmithKline).

Aclometasone dipropionate cream is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients aged one year and older. The safety and efficacy of its use for longer than three weeks have not been established.

Generic Fexofenadine HCl Capsules (Allegra) for Allergic Rhinitis and Chronic Idiopathic Urticaria

On July 12, the FDA approved a first-time generic formulation of fexofenadine HCl 60-mg capsules (made by Barr Laboratories, Inc.; brand name Allegra, made by Aventis Pharmaceuticals, Inc.).

Fexofenadine capsules are indicated for the relief of symptoms associated with seasonal allergic rhinitis and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children aged six years and older.

Reviewed by Gary D. Vogin, MD

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....