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Recent News and Articles on the Keywords: fda + seasonal + wellbutrin  Related to the article below (Last Update: 12/1/2008)

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Recent News and Articles on the Keywords: fda + wellbutrin + web  Related to the article below (Last Update: 8/7/2008)

Safety Concerns Raised About Some Generic Drugs KTVU.com, CA - Jul 25, 2008 The FDA requires their effect be equivalent, but there can still be trouble. Consider the case of a well-known, brand-name antidepressant, Wellbutrin 300 ... The Money Times Teva Reports Second Quarter 2008 Results WELT ONLINE, Germany - Jul 28, 2008 Quarterly sales benefited primarily from the launches of generic Wellbutrin XL? (Bupropion Hydrochloride Extended-Release Tablets, 150 mg) and Risperdal? ... Record revenue at Teva beats expectations Globes Teva Pharma Q2 profit up; declares dividend - Update Trading Markets (press release) all 50 news articles »  TEVA - BRL - SNY EARNINGS PREVIEW: Europe Drug Cos' 2Q Focus On Outlook, Forex CNNMoney.com - Jul 14, 2008 An advisory panel for the Food and Drug Administration will meet on July 29 to discuss the drug, and "any hint on what the FDA is looking for would be ...NVS - PINK:NVSEF - SNY GlaxoSmithKline Q2 Net Profit Rises Trading Markets (press release), CA - Jul 23, 2008 Due to an introduction of a generic version of the 150mg dose of Wellbutrin, the drug sales dropped 27% to GBP97 million. Sales of Zofran also dropped 49% ...GSK

Seasonal affective disorder: FDA has approved Wellbutrin XL

The FDA ( Food and Drug Administration ) has approved Wellbutrin XL for prevention of major depressive episodes in patients with a history of seasonal affective disorder ( SAD ).

Wellbutrin XL ( Bupropion HCL extended release tablets ) previously was approved for treatment of major depressive disorder.

Seasonal affective disorder is characterized by recurrent major depressive episodes that usually coincide with the seasonal decrease of daylight during autumn and winter.
The depressive episodes can last up to 6 months. Although patients with seasonal affective disorder may have depressive episodes during other times of the year, the diagnosis of seasonal affective disorder requires that the number of seasonal episodes substantially outnumber the non-seasonal episodes during the individual's lifetime.

A major depressive episode is defined as the presence of 5 or more of the 9 core symptoms of major depression for at least 2 weeks.
The symptoms include: depressed mood; loss of interest; weight loss ( or other weight or appetite changes ); insomnia or hypersomnia; agitation or psychomotor retardation; fatigue; feelings of worthlessness or guilt; impaired concentration; suicidal thinking or behavior.
One of the 5 symptoms must be either depressed mood or loss of interest in activities.
Another essential feature of major depression is the presence of significant distress or impairment in social, occupational, or other important areas of functioning.
A seasonal major depressive episode is defined by the identical features.

The effectiveness of Wellbutrin XL for the prevention of seasonal affective disorder episodes was established in 3 double-blind, placebo-controlled trials in adults with a history of major depressive disorder in autumn and winter.
Treatment was initiated prior to the onset of symptoms in the autumn ( September to November ) and was discontinued following a two-week taper that began the first week of spring ( fourth week of March ).
In these trials, the percentage of patients who were depression-free at the end of treatment was significantly higher for those on Wellbutrin XL than for those on placebo; for all 3 studies combined, the overall rate of patients depression-free at the end of treatment was 84 percent for those on Wellbutrin XL compared to 72 percent for those on placebo.

Wellbutrin XL’s labeling includes a “black box” warning concerning the increased risk of suicidal thoughts and behavior in pediatric patients treated with antidepressant medications.
As with all antidepressants, Wellbutrin XL has a Medication Guide advising that pediatric patients on antidepressants should be watched closely for these serious symptoms.

Important side effects to watch for with Wellbutrin XL, especially shortly after the initiation of the treatment, include agitation, anxiety and insomnia.
Wellbutrin was safe and well tolerated by patients in the seasonal affective disorder trials.

It is important to note that Wellbutrin XL is indicated only for patients who meet strict diagnostic criteria of seasonal major depressive episodes. Such patients have a pattern of recurrent, clinically significant depressive symptoms with associated impairment of functioning. The clinician and patient should carefully assess the potential risks and benefits when considering treatment with Wellbutrin XL for seasonal affective disorder.

Source: FDA, 2006