First-Time Generic Approvals: Cleocin, Celexa, Wellbutrin SR, Monopril HCT

Yael Waknine

January 28, 2005

Jan. 28, 2005 — The U.S. Food and Drug Administration (FDA) has approved first-time generic formulations of clindamycin phosphate vaginal cream 2% [base]; citalopram hydrobromide oral solution 10-mg [base]/5-mL; 200-mg bupropion hydrochloride extended-release tablets; and fosinopril sodium/hydrochlorothiazide tablets (10-mg/12.5-mg and 20-mg/12.5-mg)

Generic Clindamycin Phosphate Vaginal Cream (Cleocin) for Bacterial Vaginosis

On Dec. 27, the FDA approved a first-time generic formulation of clindamycin phosphate vaginal cream, USP 2% [base] (made by Altana, Inc.; brand name Cleocin, made by Pharmacia and Upjohn).

Clindamycin phosphate vaginal cream 2% is indicated for the treatment of bacterial vaginosis. It can be used to treat nonpregnant women and pregnant women during the second and third trimester.

Generic Citalopram HBr Oral Solution (Celexa) for Depression

On Dec. 13, the FDA approved a first-time generic formulation of citalopram hydrobromide oral solution, 10-mg [base]/5-mL (made by Roxane Laboratories, Inc.; brand name Celexa Oral Solution, made by Forest Laboratories, Inc.).

Citalopram oral solution is indicated for the treatment of depression.

Generic 200-mg Bupropion ER (Wellbutrin SR) for Depression

On Dec. 3, the FDA approved a first-time generic formulation of 200-mg bupropion HCl extended-release tablets, USP (made by Impax Laboratories, Inc.; brand name Wellbutrin SR, made by GlaxoSmithKline).

Bupropion extended-release tablets are indicated for the treatment of depression.

Generic Fosinopril Sodium/HCTZ (Monopril HCT) for Hypertension, Heart Failure

On Dec. 3 and Dec. 17, the FDA approved first-time generic formulations of fosinopril sodium plus hydrochlorothiazide tablets (Andrx Pharmaceuticals, LLC, and Ranbaxy Laboratories, Ltd.; brand name Monopril HCT, made by Bristol-Myers Squibb) in 10-mg/12.5-mg and 20-mg/12.5-mg strengths.

Fosinopril plus hydrochlorothiazide is indicated for the treatment of hypertension. It is also indicated for adjunctive therapy in the treatment of heart failure.

Reviewed by Gary D. Vogin, MD

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