As of yet, the US Food and Drug Administration has not approved Dapoxetine Hydrochloride (HCL), but nevertheless, many researches conducted worldwide show that this medicine is safe and effective for treatment of premature ejaculation. Numerous states of the world are leaping ahead and accept regulations and approving laws. European countries are the first ones in this run of making approvals for new drugs. And most probably, that European men suffering from premature ejaculation will enjoy a new cure – Dapoxetine HCL – and it will be far earlier than in the US. In December 2007, a group of European Janssen-Cilag companies submitted their Marketing Authorization Application (abbreviated as MAA) for Dapoxetine HCL, as a cure for premature ejaculation with patients’ age range starting from 18 to 64 years old.
In Europe, submission of MAA is held as decentralized procedure with Sweden acting as reference country, and with Germany, Austria, Italy, Spain, Portugal and Finland being so called Concerned Member States. It is expected that other countries worldwide will follow this experience in regulatory approvals for Dapoxetine HCL.
Our web-site contains the latest news and detailed information concerning premature ejaculation dysfunction and Dapoxetine HCL as a medium for its treatment. There may be discussions of products and therapy methods yet not approved by US FDA, including also off-label usage of the approved medicines.
It should be understood that information contained in this site is in no case a replacement for qualified doctor’s prescriptions. In any case, please, take consultations of a doctor before taking any medicine for premature ejaculation treatment.