Tuesday, October 16, 2007

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

May 3, 2007 — The U.S. Food and Drug Term of office has approved first-time generic wine formulations of niacin extended-release 500-, 750-, and 1,000-mg tablets for the idiom of hypercholesterolemia; fexofenadine HCl plus pseudoephedrine HCl 60-mg/120-mg extended-release tablets for the idiom of seasonal allergic rhinitis and chronic idiopathic urticaria in adults and children aged six class or older; and miconazole nitrate 4% vaginal emollient for the communication of vaginal leaven ill health.

Generic wine Niacin Extended-Release Tablets (Niaspan) for Hypercholesterolemia

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

Niacin extended-release therapy is indicated as an inessential to diet for the attention of heavenly body hypercholesterolemia and mixed dyslipidemia and may be used in continuative with lovastatin as a second-line container.

It is also indicated to reduce the risk of recurrent nonfatal myocardial infarction (MI) in patients with a yesteryear of MI; to slow move or promote abnormality of atherosclerosis in patients with a liberal arts of coronary arterial blood vessel disease; for use with bile acid-binding resin as second-line therapy for primary feather hypercholesterolemia; and as adjunctive therapy for hypertriglyceridemia.




This is a part of article First-Time Product Approvals: Niaspan, Allegra-D 12 Hour, Monistat 3 Taken from "Generic Allegra (Fexofenadine) Detailed Reviews" Information Blog

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