The R.W. Johnson Pharmaceutical
Research Institute (PRI), a member of the Johnson & Johnson family of
companies, submitted its New Drug Application (NDA) for the Ortho Evra(TM)
(norelgestromin/ethinyl estradiol) transdermal system, a seven-day
contraceptive patch, to the U.S. Food and Drug Administration.
The FDA's standard review period for an NDA is 12 months. If approved,
Ortho Evra would be the world's first prescription transdermal contraceptive.
Ortho Evra is a new method of combination hormonal contraception designed
to deliver continuous levels of norelgestromin and ethinyl estradiol
(progestin and estrogen, respectively) for a seven-day period. Norelgestromin
is the primary active metabolite of norgestimate, the progestin used in a
leading U.S. oral contraceptive.
Ortho Evra can be worn on several areas of a woman's body -- most
typically the lower abdomen or buttocks. The patch is worn for one week at a
time and is changed on the same day of the week three times a month. The
fourth week is patch-free.
Based in Raritan, New Jersey, PRI conducts pharmaceutical research and
development for the pharmaceutical companies of Johnson & Johnson.
Information about Ortho-McNeil products can be found on the Internet at