Ortho-McNeil seeks NDA for premature ejaculation drug

Share this article:
Johnson & Johnson's Ortho-McNeil is betting that premature ejaculation, or PE, is the next ED, a mass-market sexual dysfunction with big potential sales.
In December, Ortho-McNeil's Alza filed an NDA for dapoxetine, which would be the first to treat the condition should it win FDA approval.
Mountain View, Calif.-based Alza licensed dapoxetine from PPD GenuPro prior to its acquisition by Johnson & Johnson in 2001.
Alza, which specializes in drug delivery systems, had intended to add the compound to its urology and primary care products portfolio, which included Ditropan XL for overactive bladder, Elmiron for interstitial cystitis and Concerta for ADHD.
Alza, which named Medical Broadcasting Company to handle interactive work for dapoxetine, will present data from  Phase III trials in the first half of 2005.
Share this article:

Email Newsletters

More in Business Briefs

Avastin pockets another Priority Review label

It's the second for this cancer drug in two weeks.

Court invalidates some healthcare subsidies

The lawsuit has been wending its way through the courts for a while, and, although it is being deliberated in several other venues, the decision is part of a legal dispute that puts patients in the 36 states offering federal exchanges in limbo.

FDA generic division overhaul kicks in

The Food and Drug Administration has been intent on elevating and reorganizing its office of Generic Drugs since 2012.