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.

• FDA Statement

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.

• FDA Press Release (8/24/2006)
• Memo from Dr. Andrew von Eschenbach, Acting FDA Commissioner (8/24/2006)
• Memo from Dr. Steven Galson, Director, Center for Drug Evaluation and Research (8/24/2006)
• Questions and Answers (8/24/2006, updated 12/14/2006)
• Approval Letter (8/24/2006)
• Labeling (8/24/2006)
• Drug Review Package (8/29/2006)

Summary Report of Comments Received in Response to an Advanced Notice of Proposed Rulemaking (ANPRM), July 31, 2006

• FDA Statement: FDA Announces Framework for Moving Emergency Contraception Medication to Over-the-Counter Status
• Letter to Duramed Research, Inc.
• Comment Summary [HTML] [PDF]
• FDA Simultaneous Marketing ANPRM (Advanced Notice of a Proposed Rulemaking)
  • Bracketed Comment Letter Report  [HTML] [PDF]
  • Counts of Public Comment Submissions Coded By Issue [HTML] [PDF]
  • Comment Excerpts Sorted By Issue [HTML] [PDF]
  • Comments Numbers Sorted by Issue [HTML] [PDF]

• FDA Statement (8/26/2005)
• Letter to Duramed Research, Inc. (8/26/2005)
• Federal Register Notice:  Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in Both a Prescription Drug Product and an Over-The-Counter Drug Product (Advance notice of proposed rulemaking). [PDF] (8/26/2005)
• FDA Press Release
• Not Approvable Letter
• FDA's Decision Regarding Plan B: Questions and Answers
• Reproductive Health Drugs Advisory Committee, December 16, 2003, joint meeting with Nonprescription Drugs Advisory Committee. Meeting Information

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Date created: May 7, 2004, updated April 22, 2009

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