Canadian Regulatory Authorities Approve Marketing of Plan B® (levonorgestrel) Emergency Contraceptive without a Prescription
Apr 21, 2005 - 2:16:00 PM
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"Canada now becomes the 34th country that enables women to have more timely access to emergency contraception without a prescription. We intend to work with Paladin to ensure that healthcare providers, pharmacists and patients are fully educated about the availability of this product. We look forward to a decision on this critical health issue by the U.S. Food and Drug Administration."
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By Barr Pharmaceuticals, Inc.,
[RxPG] Barr Pharmaceuticals, Inc. (NYSE: BRL - News) today said that Canadian regulatory authorities have approved the marketing of the Plan B® (levonorgestrel) emergency contraceptive without a prescription. Plan B is being distributed and marketed in Canada by Paladin Labs Inc. Barr indicated that it is still awaiting approval of its wholly-owned subsidiary Duramed Pharmaceuticals Inc.'s Supplemental New Drug Application (sNDA) to market that product Over-the-Counter (OTC) in the United States for women 16 years of age and older while maintaining the prescription status for women age 15 and younger. Plan B is currently available by prescription only in the United States.
Plan B was approved for sale in Canada by Canada Health in 2000. The application to make Plan B available to women directly from Canadian pharmacists, without a prescription, was filed in 2002.
"We are pleased that Canadian regulatory authorities have recognized that Plan B is safe and effective for use by women as emergency contraceptive and will make it available without a prescription," said Bruce L. Downey, Barr's Chairman and CEO. "Canada now becomes the 34th country that enables women to have more timely access to emergency contraception without a prescription. We intend to work with Paladin to ensure that healthcare providers, pharmacists and patients are fully educated about the availability of this product. We look forward to a decision on this critical health issue by the U.S. Food and Drug Administration."
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. Effectiveness declines as the interval between intercourse and the start of treatment increases. Plan B is more effective when taken in the first 24 hours after intercourse.
The decline in efficacy from a delay in treatment is why a broad range of health professionals believe that barriers to more timely access to Plan B should be removed, including making the product broadly available without prescription.
Emergency contraception is currently available in 102 countries, 34 of which do not require a prescription, including Canada. Emergency contraception is currently available through pharmacy access programs in some pharmacies 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.
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Additional information about the news article
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About Barr Pharmaceuticals, Inc.
Barr Pharmaceuticals, Inc. and its subsidiaries are engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals. Duramed Pharmaceuticals is a wholly-owned subsidiary of Barr Pharmaceuticals, Inc.
About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian market. For more information about Paladin, please visit the Company's web site at http://www.paladinlabs.com.
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