First-Time Generic Approvals: Niaspan, Allegra-D 12 Hour, Monistat 3

Yael Waknine

May 03, 2005

May 3, 2005 — The U.S. Food and Drug Administration has approved first-time generic formulations of niacin extended-release 500-, 750-, and 1,000-mg tablets for the treatment of hypercholesterolemia; fexofenadine HCl plus pseudoephedrine HCl 60-mg/120-mg extended-release tablets for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria in adults and children aged six years or older; and miconazole nitrate 4% vaginal cream for the treatment of vaginal yeast infection.

Generic Niacin Extended-Release Tablets (Niaspan) for Hypercholesterolemia

On April 14, the FDA approved first-time generic formulations of niacin extended-release 500-,
750-, and 1,000-mg tablets (made by Barr Laboratories, Inc.; brand name Niaspan, made by Kos Pharmaceuticals, Inc.).

Niacin extended-release therapy is indicated as an adjunct to diet for the treatment of primary hypercholesterolemia and mixed dyslipidemia and may be used in conjunction with lovastatin as a second-line measure.

It is also indicated to reduce the risk of recurrent nonfatal myocardial infarction (MI) in patients with a history of MI; to slow progression or promote regression of atherosclerosis in patients with a history of coronary artery disease; for use with bile acid-binding resin as second-line therapy for primary hypercholesterolemia; and as adjunctive therapy for hypertriglyceridemia.

Generic Fexofenadine Plus Pseudoephedrine Extended-Release Tablets (Allegra-D 12 Hour) for Seasonal Allergic Rhinitis, Idiopathic Urticaria

On April 14, the FDA approved a first-time generic formulation of fexofenadine HCl plus pseudoephedrine HCl 60-mg/120-mg extended-release tablets (made by Barr Laboratories, Inc.; brand name Allegra-D 12 Hour, made by Aventis Pharmaceuticals, Inc.).

The antihistamine-decongestant combination is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children aged six years or older. It is also indicated for the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in this population.

Generic Miconazole 4% Vaginal Cream (Monistat 3) for Vaginal Yeast Infection

On March 2, the FDA approved a first-time generic formulation of miconazole nitrate 4% vaginal cream (made by Taro Pharmaceuticals USA, Inc.; brand name Monistat 3, made by Advanced Care Products).

The three-day over-the-counter miconazole topical regimen is indicated for the treatment of vaginal candidiasis infection.

Reviewed by Gary D. Vogin, MD

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