The U.S. Food and Drug Administration (FDA) has approved Wellbutrin XL(R) for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (SAD), a condition affecting about 6 percent of American adults. Wellbutrin XL is the first and only medication approved to prevent seasonal major depressive episodes.

“Seasonal affective disorder is a serious and often under-diagnosed form of depression that affects millions of people each year in the United States,” said Norman E. Rosenthal, M.D., clinical professor of Psychiatry at Georgetown Medical School and medical director of Capital Clinical Research Associates. “The FDA approval of Wellbutrin XL for the prevention of seasonal major depressive episodes in adults diagnosed with SAD is exciting. For the first time, it may be possible to prevent the predictable onset of SAD with medication by beginning treatment in the autumn season, prior to experiencing depressive symptoms.”

A combined analysis of three clinical trials showed that Wellbutrin XL reduces the chance of developing a seasonal major depressive episode by 44 percent.

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Percocet is a trademarked, potent compound painkiller used to treat moderately severe to severe acute (short-term) pain. The main ingredient of Percocet is oxycodone, a potent opioid agonist; in addition, the drug contains paracetamol, also known as acetaminophen. It is notable for its potential for drug abuse.

The U.S. Food and Drug Administration first approved Percocet in 1976, under application ANDA 085106.

Pharmacology

Endo Pharmaceuticals currently manufactures Percocet, as well as Percodan which contains oxycodone and aspirin. Percocet tablets are available in six combinations of oxycodone hydrochloride and acetaminophen, with different appearances and maximum daily doses:

* 2.5 mg oxycodone HCl & 325 mg acetaminophen: pink oval tablet, maximum daily dose 12 tablets

* 5 mg oxycodone HCl & 325 mg acetaminophen: blue round tablet, maximum daily dose 12 tablets

* 7.5 mg oxycodone HCl & 325 mg acetaminophen: peach oval tablet, maximum daily dose 8 tablets

* 7.5 mg oxycodone HCl & 500 mg acetaminophen: peach capsule-shaped tablet, maximum daily dose 8 tablets

* 10 mg oxycodone HCl & 325 mg acetaminophen: yellow capsule-shaped tablet, maximum daily dose 6 tablets

* 10 mg oxycodone HCl & 650 mg acetaminophen: yellow oval tablet, maximum daily dose 6 tablets

For the 2.5 mg oxycodone HCl tablet, the usual dose is 1-2 tablets every six hours as needed for pain; for the other tablets, the usual dose is 1 tablet every six hours as needed for pain.

Watson Laboratories manufactures generic versions of five of the six types of Percocet tablets (with 5, 7.5, and 10 mg oxycodone HCl).





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