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Article: OTC access sought for emergency contraception.
- Article from:
- Contraceptive Technology Update
- Article date:
- August 1, 2002
CopyrightCOPYRIGHT 2002 A Thomson Healthcare Company. 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)
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OTC access sought for emergency contraception
Could the United States see over-the-counter (OTC) status for emergency contraception (EC)? Washington, DC-based Womens Capital Corp. says it plans to submit an OTC application for its levonorgestrel-only drug, Plan B, to the Food and Drug Administration (FDA) in late summer 2002.
According to the company, the studies required to support the application are completed, and final data analysis is under way. Womens Capital Corp. will ask the FDA for priority review of six months or less; if the agency moves forward on the request, a decision could be reached in early 2003.
While the company moves ...