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FDA Approval for Effexor - Venlafaxine

The tablet form of branded medicine Effexor formulated by using the active generic pharmaceutical ingredient called Venlafaxine Hydrochloride manufactured by Wyeth for the treatment of major depressive disorders has been approved by the Food and Drug Administration-FDA. Also the capsule version of Effexor XR or sustained release drug has been simultaneously approved by the FDA. The drugs have been produced and launched by Wyeth-Ayerst Laboratories, the pharmaceutical division of AHP. The FDA’s approval was based on the new data that demonstrated that Effexor-Venlafaxine Hydrochloride was better than placebo in preventing relapse and showed the important decrease in intermittent occurrences or episodes, both vital features in bringing patients to recovery.

Wyeth-Ayerst submitted new labeling applications on 5th of May 2000 for Effexor XR relapse and on May 18, 2000 for Effexor recurrence based on the data from two double-blind, randomized, placebo controlled trials. The first of such trials was the six month study of 318 persons having depression showed that treating with Effexor XR –sustained release with doses of 75mg, 150mg and 225mg everyday was remarkably better than placebo at preventing relapse within 4 to 6 months of obtaining the initial treatment response. However, the second and longer trial of 12 month’s study on 235 people having depression exhibited that treatment with Effexor showed the considerable decrease in recurrent depressive occurrences.

Thus since approval of these drugs, they have been helping millions of people with depression leading fuller lives. The new labeling approval by the FDA would help the company providing with millions of Americans with depression not only relief from their symptoms but also recovery which is of course the ultimate goal of any treatment.
 

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