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FDA Approval for
Dapoxetine |
Dapoxetine was originally created by the biochemist David T. Wong
for Eli Lily and Company and was known as LY 210448 and was being
developed as the antidepressant drug. The company then sold its
rights to Johnson & Johnson for $65 million during December 2003.
The formal approval of any drug by the competent authority called
the Food and Drug Administration - FDA functioning in the particular
country is mandatory before launching it in the open markets.
Without such authentication, no medication is ever permitted to be
manufactured and sold in the market across the world.
Accordingly, this drug too was submitted to the Food and Drug
Administration - FDA as Dapoxetine Hydrochloride by ALZA Corporation
and its present company named Johnson & Johnson for treating the
Premature Ejaculation-PE with the New Drug Application-NDA precisely
on 28th December 2004. However, in response to the company’s such
application, the Food and Drug Administration - FDA has issued the
‘Non-approvable’ letter during October 2005.
In spite of completion of two official clinical trials during the
year 2006, the experts yet doubt about its approval by the Food and
Drug Administration - FDA in the near future just because the
Selective Serotonin Reuptake Inhibitors - SSRIs have the tendency of
certain unnecessary side effects following its prolonged usage which
generally include: psychiatric predicaments, dermatological
reactions, increase in the body weight, reduced sex drives, nausea,
headaches, stomach upset and general weakness. Thus Dapoxetine is
not considerably compensating the benefit of premature ejaculation
medication against the risk factors.
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