The Food and Drug Administration approved labeling that will allow 17-year-olds access to the Plan B emergency-contraceptive pill without a prescription.
The agency also approved a one-dose version of the product called Plan B One-Step that will also be available over the counter to women age 17 and older. Both products are sold by Duramed Pharmaceuticals, a unit of Teva Pharmaceuticals Industries Ltd.
Duramed loses market exclusivity on the traditional Plan B pill—which is taken in two steps—next month, allowing generic versions to be made available. Teva said the Plan B One-Step would be available in pharmacies next month.
In March a federal court ordered the FDA to lower the age requirement set by the Bush administration for Plan B to be sold over the counter, to 17 from 18.
In 2006, the FDA agreed to make Plan B available without a prescription to women over 18 and required the product to be placed behind the pharmacy counter. In 2004, the FDA rejected an application to make Plan B available without a prescription even though an advisory panel of outside medical experts voted to support the switch from prescription to nonprescription status.
Plan B was approved as a prescription “emergency” contraceptive in 1999. It is made of the hormone progestin, and is designed to prevent pregnancy if taken within 72 hours of unprotected sexual intercourse. The original Plan B pill is designed to be taken in two doses, 12 hours apart.
The pills are similar to birth-control pills but contain higher doses of progestin to block a potentially fertilized egg from becoming implanted in a woman’s uterus.
The court ruling came in response to a lawsuit filed in 2005 by the Center for Reproductive Rights, a women’s health advocacy group.
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