Bupropion News and Research

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FDA schedules Advisory Committee meeting to review Orexigen's Contrave NDA

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration (FDA) has tentatively scheduled a Division of Metabolic and Endocrine Drug Products Advisory Committee meeting on December 7, 2010 to review the Company's New Drug Application (NDA) for Contrave® (naltrexone sustained release (SR)/bupropion SR) for the treatment of obesity.

24 Jun 2010

FDA assigns PDUFA action date for Orexigen's Contrave NDA review

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration has assigned a Prescription Drug User Fee Act (PDUFA) action date of January 31, 2011 for the review of the Contrave® (naltrexone sustained release (SR)/bupropion SR) New Drug Application (NDA).

17 Jun 2010

FDA accepts Orexigen's Contrave NDA for treatment of obesity

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company's New Drug Application (NDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity.

2 Jun 2010

Computerized bilingual decision aid can prompt Hispanic smokers to quit: Study

A computerized bilingual decision aid - placed in safety-net clinics and health fairs - can prompt Hispanic and other smokers to set a quit date and choose effective treatments.

12 May 2010

Mylan Pharmaceuticals receives FDA approval for Bupropion HCl ER Tablets

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Bupropion Hydrochloride Extended-release Tablets USP, 150 mg, the generic version of GlaxoSmithKline's smoking cessation aid, Zyban.

4 May 2010

Mylan Pharmaceuticals' ANDA for generic Wellbutrin SR receives FDA final approval

Mylan Inc. today announced that its subsidiary Mylan Pharmaceuticals Inc. received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets USP, (SR), 100 mg, 150 mg and 200 mg, the generic version of GlaxoSmithKline's antidepressant Wellbutrin SR®.

12 Apr 2010

USFDA approves Sun Pharmaceutical Industries' ANDA for generic Wellbutrin SR Extended Release tablets

Sun Pharmaceutical Industries Ltd. announced that USFDA has granted its subsidiary an approval for its Abbreviated New Drug Application (ANDA) to market a generic version of GlaxoSmithKline's Wellbutrin SR® Extended Release tablets.

8 Apr 2010

Orexigen Therapeutics announces submission of Contrave NDA for treatment of obesity

Orexigen® Therapeutics, Inc. announced that the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Contrave® (naltrexone SR/bupropion SR), its investigational drug for the treatment of obesity. The NDA is based on a substantial body of evidence gathered through the Contrave Obesity Research (COR) clinical program, which included over 4,500 patients.

1 Apr 2010

Changing drug therapy can help breast cancer patients get full benefit of tamoxifen treatment

26 Mar 2010

Changing drug therapy can help breast cancer patients get full benefit of Tamoxifen

Recently published research has shown that some breast cancer patients taking tamoxifen may not be getting the full benefit of their treatment because they have also been taking selective serotonin reuptake inhibitors (SSRIs), prescribed drugs that inhibit the effect of an important enzyme. Now researchers have developed a strategy for overcoming this problem, the seventh European Breast Cancer Conference (EBCC7) in Barcelona will hear today (Wednesday).

25 Mar 2010

Combining cognitive behavioral therapy with medication bupropion helps women quit smoking

For women smokers worried about their weight, combining cognitive behavioral therapy addressing weight concerns with the medication bupropion appears more effective than counseling alone to help them quit smoking, according to a report in the March 22 issue of Archives of Internal Medicine, one of the JAMA/Archives journals.

23 Mar 2010

Patheon's first-quarter fiscal 2010 total revenues up 5.2%

Patheon a global provider of drug development and manufacturing services to the international pharmaceutical industry today announced results for its first quarter ended January 31, 2010. All amounts are in U.S. dollars unless otherwise indicated.

15 Mar 2010

Orexigen Therapeutics, Patheon sign long-term agreement for commercial manufacturing of Contrave

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, and Patheon Inc., a global provider of drug development and manufacturing services, announced today a long-term agreement for commercial manufacturing of Contrave® (naltrexone HCL sustained release (SR)/bupropion HCL SR) as well as development of future formulations of Orexigen products.

15 Mar 2010

Orexigen Therapeutics reports net loss of $15.0M for three months ended December 31, 2009

Orexigen® Therapeutics, Inc., a biopharmaceutical company focused on the treatment of obesity, today announced financial results for the three months and year ended December 31, 2009.

9 Mar 2010

Watson Laboratories files ANDA for generic Aplenzin ER in treatment of major depressive disorder

Watson Pharmaceuticals, Inc., a leading global specialty pharmaceutical company, today confirmed that its subsidiary, Watson Laboratories, Inc.- Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration seeking approval to market its 174 mg and 348 mg strength bupropion hydrobromide tablets prior to the expiration of patents owned by Biovail. Watson's 174 mg and 348 mg strength bupropion hydrobromide tablet products are generic versions of Biovail's Aplenzin™ ER, which is indicated for major depressive disorder.

23 Feb 2010

Biovail comments on Teva Pharmaceutical's proposed Budeprion XL trial

Biovail Corporation today commented on a proposed clinical trial recently announced by Teva Pharmaceutical Industries Ltd. According to Teva, the trial is intended to address reports of inefficacy and adverse events by consumers who switched from Wellbutrin XL® 300 mg, Biovail’s FDA-approved brand of the antidepressant, bupropion hydrochloride, to Budeprion XL, Teva’s generic formulation of the drug. The trial was described in a Dow Jones Newswire article dated December 2, 2009.

22 Jan 2010

USPTO issues Notice of Allowance for IntelGenx's bupropion patent

IntelGenx Corp. ("IntelGenx") today announced that the U.S. Patent and Trademark Office ("USPTO") has issued a formal Notice of Allowance for a key patent application protecting IntelGenx's CPI-300, a novel, high strength formulation of bupropion hydrochloride ("HCl"), the active ingredient in Wellbutrin XL(R).

21 Jan 2010

IQWiG calls for mandatory registration and publication of all clinical trial results

Today the Institute for Quality and Efficiency in Health Care (IQWiG) is calling for registration and publication of the results of all clinical trials to be made obligatory.

25 Nov 2009

Reboxetine drug does not alleviate depression, says new study

There is no scientific proof that people suffering from depression can benefit from taking reboxetine. However, clinical trials do provide proof of benefit of bupropion XL and mirtazapine: both agents can alleviate symptoms. This is the conclusion of the final report of the Institute for Quality and Efficiency in Health Care (IQWiG) published on 24 November 2009.

24 Nov 2009

States are not taking enough efforts to help smokers quit: American Lung Association

As the debate over health care reform dominates the media and political arena, a new American Lung Association report finds that states aren't doing enough to help smokers quit - and policymakers must fix this in the health care reform process.

11 Nov 2009