Barr's Plan B OTC emergency contraceptive "not approvable"; FDA offers two options for further submissions
Barr's Plan B OTC emergency contraceptive "not approvable"; FDA offers two options for further submissions
WOODCLIFF LAKE, N.J., May 6, 2004 -- Barr Pharmaceuticals announced that it has received a Not Approvable Letter from the FDA for the company's Supplemental New Drug Application (sNDA) for an over-the-counter (OTC) Plan B emergency contraceptive product.
Although concluding that Barr's current application did "not provide adequate data to support a conclusion that Plan B can be used safely by young adolescent women for emergency contraception without the professional supervision of a [licensed] practitioner", the FDA offered Barr two alternative approaches for seeking approval. First, Barr could "provide additional data demonstrating that Plan B can be used safely by women under 16 years of age without professional supervision". Alternatively, Barr could "supply additional information in support of a submission to allow for the marketing of Plan B as a prescription only product for women under the age of 16 years and a nonprescription product for women 16 years and older".
"While we are disappointed that FDA did not approve our application at this time, we are encouraged by FDA's suggestions, and look forward to working with the agency toward approval of Plan B for over the counter use," said Bruce L. Downey, Barr's Chairman and CEO. "In the meantime, we remain committed to providing Plan B as a prescription only product and to increasing awareness among the healthcare provider community and women of this safe and effective option."
Taken within 72 hours of unprotected intercourse, Plan B has been shown to reduce the risk of pregnancy by 89 percent after a single act of unprotected sex. Plan B is most effective when taken in the first 24 hours after intercourse. Effectiveness declines as the interval between intercourse and the start of treatment increases. The major side effect associated with Plan B is nausea.
Emergency contraception is currently available in 101 countries, 33 of which do not require a prescription. Emergency contraception is currently available in a limited number of pharmacies without an advance prescription from a physician or healthcare provider in six U.S. states (Alaska, California, Hawaii, Maine, New Mexico and Washington).
Contraindications for Plan B
Progestin-only contraceptive pills (POPs) are used as a routine method of birth control over longer periods of time, and are contraindicated in some conditions. It is not known whether these same conditions apply to the Plan B regimen consisting of the emergency use of two progestin pills. POPs are not recommended for use in the following conditions: known or suspected pregnancy; hypersensitivity to any component of the product; and, undiagnosed abnormal genital bleeding.
SOURCE Barr Pharmaceuticals www.barrlabs.com
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