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FDA Approval for Paroxetine – Paxil CR

In accordance to the information provided by the manufacturer of Paxil CR, GlaxoSmithKline and with the recommendations from FDA, the sale of this drug has helped many people treat major depressive disorder which has come forward after six sucessful placebo-controlled clinical trials. The clinical trials and experiments on the pill have proved successful with a list of side effects too and that comes with every medicine.

Future use of Paroxetine also appears positive and promising; but it cannot be purchased without a registered prescription. The FDA specifically will check up on medications and their addictive qualities and will allow their dosage and availability to be in accordance to safety and that is why Paxil CR has undergone a serious lawsuit trial from FDA which says that it has been promoting Paxil for the prescription of children which was denied by the GlaxoSmithKline Company.

The settlement agreement between FDA and GSK states that it previously prescribed medicine for the child should be recover upto 100% is the documentation is not present. Among the primary tasks of GSK are included tasks like certifing their safety, purity and even potency before they are marked to be shipped. FDA also ensures that the labelling on Paroxetine must be precise and clear for its effective use. So after extensive research it was found that GSK has not done any of these alleged things and found that if teenager has taken this drug it will increase the risk of suicide by 60%. So after such strict action Paxil CR was approved by FDA in 2007.
 

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