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Entries in Teva Pharmaceutical (1)

Monday
Feb282011

Drug Maker Wants to Lift Age Restrictions on Morning After Pill

Photo Courtesy - Joe Raedle/Getty Images(WASHINGTON) -- Teva Pharmaceutical Industries Ltd., the maker of Plan B One-Step, has requested that the U.S. Food and Drug Administration switch this "morning after" pill to full nonprescription status for women of all ages.

Currently, women 17 and older can buy the high-dose birth control pill over-the-counter, without a prescription.  Those younger than 17 need a prescription to obtain the high-dose hormone pill.

"Our 2003 Plan B application and our current application for Plan B One-Step is seeking over-the-counter status for the product based on data that demonstrate the product meets the scientific criteria that the FDA has established for over the counter products," said Denise Bradley, senior director of corporate communications at Teva Pharmaceuticals.  "Label comprehension and safety data show that all women are able to safely and effectively take this product.  It is not typical for any women's health product to have age restrictions."

Plan B, or levonorgestrel, is a progestin-only emergency contraceptive that can prevent a fertilized egg from attaching to the wall of uterus if taken within 72 hours of unprotected sex.  The drug is not effective if the woman is already pregnant, and it does not pose harm to a fetus.

According to Jeff Ventura, a spokesman for the FDA, a prescription drug may be eligible for over-the-counter status if it is determined that dispensing the drug by prescription is not necessary for the protection of the public health, and the drug is safe and effective for use in self-medication as directed in proposed labeling.

"The application will go through the normal FDA review process," said Ventura in a statement.  "It will be evaluated against the same scientific and regulatory criteria as all other over-the-counter switch applications."

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