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FDA Approval Sought for Transdermal System.

Women's Health Weekly

| January 18, 2001 | COPYRIGHT 2001 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

2001 JAN 18 (NewsRx.com) -- The R.W. Johnson Pharmaceutical Research Institute (PRI), Raritan, New Jersey, submitted its New Drug Application (NDA). for the Ortho Evra (norelgestromin/ethinyl estradiol) transdermal system to the U.S. Food and Drug Administration (FDA).

Ortho Evra is a seven-day contraceptive patch. 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 method of combination hormonal contraception designed ...

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