Janssen-Cilag has submitted an MAA for dapoxetine, a treatment for premature ejaculation (PE) in men 18-64 years of age. The MAA was submitted under the decentralised procedure, in which Sweden will act as the Reference Member State, and Austria, Finland, Germany, Italy, Portugal and Spain will act as the Concerned Member States for the application. Regulatory submissions in other regions of the world are expected to follow. Dapoxetine is the first oral pharmacologic agent developed specifica...