Bupropion News and Research

RSS

Contrave added to diet and exercise regimen can induce significant weight loss

Orexigen Therapeutics, Inc. announced the online publication of results from its COR-BMOD trial of Contrave (naltrexone SR/bupropion SR) in the journal Obesity. The COR-BMOD trial evaluated intensive behavior modification plus Contrave32 (32mg naltrexone sustained release (SR)/360mg bupropion SR) compared to BMOD plus placebo, in 793 overweight or obese patients.

4 Aug 2010

Orexigen's Contrave COR-I trial results published online in journal Lancet

Orexigen® Therapeutics, Inc. announced that results from its COR-I trial of Contrave® were published online today in the journal Lancet. COR-I was the largest of the four, 56-week, Phase 3 trials supporting the New Drug Application for Contrave, currently under review by the U.S. Food and Drug Administration. Results show that patients taking Contrave were two to three times more likely to lose at least 5% or 10% of their body weight compared to those taking placebo, on both an intent-to-treat (ITT) and completers basis.

30 Jul 2010

Caraco Pharmaceutical Laboratories begins marketing bupropion hydrochloride extended release tablets

Caraco Pharmaceutical Laboratories, Ltd. has started shipping bupropion hydrochloride extended release tablets. This product was recently approved by the US Food and Drug Administration (FDA) for Sun Pharma's Abbreviated New Drug Application (ANDA). These bupropion hydrochloride extended release tablets, 100 mg, 150 mg, and 200 mg, are therapeutically equivalent to GlaxoSmithKline's Wellbutrin SR® Extended Release tablets.

22 Jul 2010

Actavis Group receives FDA approval to market Bupropion HCl SR tablets

Actavis Group, the international generic pharmaceuticals company, today announced that it has received approval from the U.S. Food & Drug Administration to market Bupropion HCl Extended-Release tablets 100mg and 200mg. Distribution of the product will commence immediately.

22 Jul 2010

Combination therapy for severe depression

Severe depression is life threatening. So it is worth every effort to get depression under control and make life more manageable. For most people, that means some combination of antidepressant drugs and talk therapy.

29 Jun 2010

Orexigen Therapeutics announces data from CORDiabetes trial for Contrave

Orexigen Therapeutics, Inc. today announced data from the CORDiabetes trial for Contrave (naltrexone sustained release (SR)/bupropion SR) showing that after 56 weeks of treatment, overweight or obese patients with type 2 diabetes lost significantly more weight and achieved greater improvement in glycemic control than those treated with placebo.

28 Jun 2010

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.