April 23, 2009
FDA action on Plan B tablets updatedDuramed will be allowed to market Plan B (levonorgestrel) without a prescription to women 17 years of age and older upon submission and approval of an appropriate application. 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. This is an update to the August 24, 2006 action that approved the switch of Plan B from prescription to over-the-counter status for women ≥18years old.
Plan B is indicated for the prevention of pregnancy after known or suspected contraceptive failure or unprotected intercourse.
For more information call (877) 405-0369 or visit www.fda.gov/cder/drug/infopage/planB/default.htm.