FiercePharma

FDA Update: Budeprion XL 300 mg Not Therapeutically Equivalent to Wellbutrin XL 300 mg

The U.S. Food and Drug Administration (FDA) has reviewed new data that indicate Budeprion XL 300 mg (bupropion hydrochloride extended-release tablets), manufactured by Impax Laboratories, Inc., and ...
FiercePharma

Mylan Confirms Approval of sANDA for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg

PITTSBURGH, Aug. 22, 2013 -- Mylan Inc. (Nasdaq: MYL) today confirmed that the company has received approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug ...
Drug Store News

FDA issues new guidelines for budeprion XL in the 300-mg strength

WASHINGTON — The Food and Drug Administration has reviewed new data that indicated that budeprion XL (bupropion hydrochloride extended-release tablets) in the 300-mg strength, manufactured by Impax ...
Medical Xpress

FDA pulls one generic form of wellbutrin off the market

(HealthDay)—People taking the antidepressant Wellbutrin now have one less option for a generic version of the drug. In October, the U.S. Food and Drug Administration recommended that generic ...
Medscape

First-Time Generic Approvals: Oral Zofran, Wellbutrin XL, Kefzol Bulk Packages

January 5, 2007 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for ondasetron tablets, orally disintegrating tablets, and oral solution for the prophylaxis of ...
Medscape

FDA Withdraws Approval of Generic Antidepressant

October 4, 2012 — The antidepressant Budeprion XL 300 mg, one of the generic formulations of extended-release bupropion hydrochloride, is not therapeutically equivalent to Wellbutrin XL 300 mg, the ...
MM&M

Generic form of Wellbutrin XL approved

The first US generic form of GlaxoSmithKline’s Wellbutrin XL has been approved by the FDA. Anchen Pharmaceuticals’ bupropion HCl extended-release tablets are available in 150 mg and 300 mg strengths.
RAPS

A Generic Conundrum: How do you Study a Drug that has Been Withdrawn from the Market?

In March 2013, the US Food and Drug Administration (FDA) formally withdrew approval for Impax Laboratory's buproprion hydrochloride extended release 300 mg (Budeprion XL 300 mg), saying the drug had ...
EurekAlert!

FDA approves Wellbutrin XL(TM)

Research Triangle Park, NC (August 28, 2003) -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration has approved Wellbutrin XL™ (bupropion hydrochloride extended-release tablets ...
CNBC

Generic antidepressant not equivalent to original Wellbutrin -FDA

Oct 6 (Reuters) - The U.S. Food and Drug Administration saidnew data indicate that the generic version of the popularantidepressant Wellbutrin is not equivalent to the original drugmanufactured by ...
Monthly Prescribing Reference

FDA Update: Budeprion XL 300mg Not Therapeutically Equivalent to Wellbutrin XL 300mg

The FDA has reviewed new data that indicate Budeprion XL 300mg (bupropion HCl extended-release tablets; Impax Laboratories), marketed by Teva, is not therapeutically equivalent to GlaxoSmithKline‘s ...