Drugs
Plan B (0.75mg levonorgestrel) and Plan B One-Step (1.5 mg levonorgestrel) Tablets Information
FDA Approves Plan B One-Step Emergency Contraceptive; Lowers Age for Obtaining Two-Dose Plan B Emergency Contraceptive without a Prescription
The U.S. Food and Drug Administration approved Plan B One-Step, a single dose emergency contraceptive containing levonorgestrel 1.5 mg in a single tablet. The FDA also announced a change in the labeling of Plan B, currently marketed as an emergency contraceptive consisting of two levonorgestrel 0.75 mg tablets taken 12 hours apart.
Plan B has been available to women 18 years of age and older without a prescription and to women younger than 18 years of age only by prescription since August 2006.
With the FDA's action, both Plan B One-Step and Plan B will be available without a prescription to women 17 years of age and older. They will both be available for women younger than 17 years of age only by prescription.
Historical 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)
Background Information
Summary Report of Comments Received in Response to an Advanced Notice of Proposed Rulemaking (ANPRM), July 31, 2006
Other Information
- Plan B One-Step Approval Letter
Plan B One-Step (levonorgestrel) tablet, 1.5 mg Approval Letter - Plan B One-Step label
Plan B One-Step Highlights of Prescribing Information - FDA Takes Action on Plan B
- 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