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Research Institute submits application for FDA approval of new contraceptive Ortho Evra Transdermal System
Agencies, N.J. | Thursday, December 28, 2000, 08:00 Hrs  [IST]

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 (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.

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