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FDA Approves Enhanced Pregnancy Prevention Program For Accutane.(Hoffmann-La Roche Inc.'s Pregnancy Prevention Program for Women on Accutane)

Women's Health Weekly

| December 06, 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 DEC 6 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration (FDA) has approved an enhanced version of Roche's Pregnancy Prevention Program for Women on Accutane (PPP), according to Hoffmann-La Roche, Inc.

The revised program is intended to assist physicians, patients, and

pharmacists in further reducing the number of pregnancies among women taking Accutane (isotretinoin), Roche's product for severe recalcitrant nodular acne, because of the medication's risk of causing birth defects. The Roche program, called SMART, for System to Manage Accutane-Related Teratogenicity, consists of informational brochures for physicians, pharmacists, and patients as well as letters explaining the new aspects of the program. It will be distributed in January ...

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Source: HighBeam Research, FDA Approves Enhanced Pregnancy Prevention Program For...

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