First-Time Generic Approvals: Terazol 7, DDAVP Nasal Spray, Biaxin XL, ThyroSafe

Yael Waknine

February 18, 2005

Feb. 18, 2005 — The U.S. Food and Drug Administration (FDA) has approved a first-time generic formulation of terconazole vaginal cream 0.4% for the treatment of vulvovaginal candidiasis; a first-time formulation of desmopressin acetate 0.01% nasal solution for the treatment of nocturnal enuresis and diabetes insipidus; a first-time and a generic formulation of clarithromycin 1 g extended-release tablets for the treatment of bacterial infections; and a first-time and a generic formulation of potassium iodide 65 mg/mL oral solution for use as a thyroid-blocking agent in radiation emergencies.

Generic Terconazole Vaginal Cream 0.4% (Terazol 7) for Vulvovaginal Candidiasis

On Jan. 19, the FDA approved a first-time generic formulation of terconazole vaginal cream 0.4% (made by Taro Pharmaceuticals USA, Inc.; brand name Terazol 7, made by Johnson & Johnson Research and Development, LLC).

Terconazole vaginal cream 4% is indicated for the local treatment of vulvovaginal candidiasis.

Generic Desmopressin Acetate Nasal Spray (DDAVP) for Nocturnal Enuresis, Diabetes Insipidus

On Jan. 27, the FDA approved a first-time generic formulation of desmopressin acetate nasal solution 0.01% (made by Apotex, Inc.; brand name DDAVP, made by Aventis Pharmaceuticals, Inc.). It is the first generic formulation of the product that does not require refrigeration.

Desmopressin acetate nasal spray is indicated for the management of primary nocturnal enuresis and for antidiuretic replacement therapy in the management of central diabetes insipidus. It is also indicated for the management of the temporary polyuria and polydipsia after head trauma or surgery in the pituitary area.

Generic Clarithromycin 1 g Extended-Release (Biaxin XL Filmtab) for Bacterial Infections

On Jan. 26, the FDA approved a first-time and a generic formulation of clarithromycin 1 g extended-release tablets (made by Ranbaxy Laboratories, Ltd.). The 1-g generic formulation is considered to be equivalent to two 500-mg tablets of the brand-name formulation (Biaxin XL Filmtab, made by Abbott Laboratories, Inc.).

Clarithromycin extended-release tablets are indicated for the treatment of mild to moderate bacterial infections caused by susceptible strains of aerobic and anaerobic gram-positive and gram-negative microorganisms, including most Mycobacterium avium complex (MAC) microorganisms.

Generic ThyroShield Oral Solution (ThyroSafe) for Radiation Emergencies

On Jan. 12, the FDA approved a first-time and generic formulation of potassium iodide 65-mg/mL oral solution (ThyroShield, made by Fleming & Company Pharmaceuticals). It is considered to be equivalent to the brand-name 65-mg tablet (ThyroSafe, made by Recip AB, Sweden, for Recip US, U.S.A.) when dissolved in liquid for oral administration.

Potassium iodide oral solution is indicated for use as a thyroid-blocking agent in nuclear radiation emergencies.

Reviewed by Gary D. Vogin, MD

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