Related Information

• FDA approves Plan B One-Step emergency contraceptive without a prescription for women 15 years of age and older
  FDA news release (4/30/2013)
• Response to Citizen Petition (Docket 2001P-0075/CP1), Center for Reproductive Rights  (PDF - 79KB)
  (12/12/2011)
• Statement from FDA Commissioner Margaret Hamburg, M.D. on Plan B One-Step
  (12/7/2011)
• Updated FDA Action on Plan B (levonorgestrel) Tablets [ARCHIVED]
  (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

• FDA Announces Framework for Moving Emergency Contraception Medication to Over-the-Counter Status

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

Labeling and Regulatory History from Drugs@FDA

• Levonorgestrel (markerted as Plan B) Prescribing and Labelng Information