NMA: Nonprescription Medicines Academy

Emergency Contraceptives Now OTC for All Women

August 22nd, 2013

The FDA has approved the use of Plan B One-Step (single-dose levonorgestrel 1.5 mg) as a nonprescription product for all women of child-bearing potential. This action complies with the April 5, 2013, order of the U.S. District Court in New York to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions.

Plan B One-Step was first approved in July 2009 for use without a prescription for women 17 years of age or older and as a prescription-only option for women younger than 17 years. In April 2013, the product was approved for nonprescription use for women as young as 15 years of age.

The FDA asked Teva Women’s Health (the manufacturer of Plan B One-Step) to submit a supplemental application seeking approval of the one-pill product to be made available without any restrictions. According to a news release issued by the agency, FDA “has fulfilled its commitment to the court by promptly completing its review and approval of the supplemental application.”

Teva will make the product available in retail outlets with an on-site pharmacy.