Drugs
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Plan B (0.75mg levonorgestrel) and Plan B One-Step (1.5 mg levonorgestrel) Tablets Information
Over-the-counter Plan B, Plan B One-Step, and their generic versions are approved to allow OTC availability of these products for consumers 17 years and older. Plan B, Plan B One-Step, and their generic versions remain available by prescription only for women 16 years and younger.
Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step (Dec. 7, 2011)
Response to Citizen Petition (Docket 2001P-0075/CP1), Center for Reproductive Rights (Dec. 12, 2011) [PDF, 69KB]
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Related Information
Updated FDA Action on Plan B (levonorgestrel) Tablets
(4/22/2009)FDA Approves Over-the-Counter Access for Plan B for Women 18 and Older
(8/24/2006)Plan B - Memo from Dr. Andrew von Eschenbach (PDF - 102KB)
(8/24/2006)Plan B - Memo from Dr. Steven Galson (PDF - 45KB)
(8/24/2006)Plan B: Questions and Answers - August 24, 2006; updated December 14, 2006 Approval Letter - Plan B (levonorgestrel) Tablets, 0.75 mg
(8/24/2006)Labeling - Plan B (0.75mg levonorgestrel) Tablets
(8/24/2006)Drug Approval Package - Plan B (0.75mg levonorgestrel) Tablets
(8/29/2006)
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Background Information
Summary Report of Comments Received in Response to an Advanced Notice of Proposed Rulemaking (ANPRM), July 31, 2006
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Additional Information
Plan B One-Step Approval Letter
(7/2009)Plan B One-Step label
(7/2009)FDA Takes Action on Plan B
(8/26/2005)Plan B - Letter to Duramed Research, Inc (PDF - 21KB)Plan B - Not Approvable Letter (PDF - 111KB)FDA's Decision Regarding Plan B: Questions and Answers 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). (8/26/2005)December 16, 2003 Joint meeting with Nonprescription Drugs Advisory Committee Advisory Committees: CDER 2003 Meeting Documents
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Labeling and Regulatory History from Drugs@FDA
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