Posted by Iansf on February 9, 2005, at 18:45:22
First-Time Generic Approvals: Celexa, Wellbutrin SR
Yael Waknine
Medscape Medical News 2005. © 2005 Medscape
Jan. 28, 2005 — The U.S. Food and Drug Administration (FDA) has approved first-time generic formulations of citalopram hydrobromide oral solution 10-mg [base]/5-mL; and 200-mg bupropion hydrochloride extended-release tablets.
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.
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