Plan B (0.75mg levonorgestrel) Tablets Information

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FDA/Center for Drug Evaluation and Research

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)

Background Information

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]

Other Information

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 August 29, 2006