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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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