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Plan B (0.75mg levonorgestrel)
Tablets Information
On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription. The government will not appeal this decision. In accordance with the court’s order, and consistent with the scientific findings made in 2005 by the Center for Drug Evaluation and Research, FDA notified the manufacturer of Plan B informing the company that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.
Historical Information
The U.S. Food and Drug Administration (FDA) announces approval of Plan B, a contraceptive drug, as an over-the-counter (OTC) option for women aged 18 and older.
Summary Report of Comments
Received in Response to an Advanced Notice of Proposed Rulemaking (ANPRM), July 31, 2006
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FDA Statement: FDA Announces Framework for Moving Emergency
Contraception Medication to Over-the-Counter Status
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Letter to Duramed Research, Inc.
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Comment Summary [HTML]
[PDF]
- FDA Simultaneous Marketing ANPRM (Advanced Notice of a
Proposed Rulemaking)
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Bracketed Comment Letter Report [HTML]
[PDF]
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Counts of Public Comment Submissions Coded By Issue [HTML]
[PDF]
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Comment Excerpts Sorted By Issue [HTML]
[PDF]
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Comments Numbers Sorted by Issue [HTML]
[PDF]
Other Information
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Date created: May 7, 2004, updated April 22, 2009 |
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