FDA to expand Plan B availability to 17-year-olds

ROCKVILLE, Md. The Food and Drug Administration on Wednesday informed Duramed Research, manufacturer of Plan B, that it may market the emergency contraceptive without a prescription to women age 17 years and older, following submission and approval of the appropriate application.

Currently, the emergency contraceptive Plan B is available behind the pharmacy counter for women over the age of 18, but as a prescription-only product for women 17 years old and younger.

The FDA decision came within the 30 days mandated by a federal court to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription.

“The government will not appeal this decision,” the FDA stated. “In accordance with the court’s order, and consistent with the scientific findings made in 2005 by the Center for Drug Evaluation and Research,  FDA notified the manufacturer of Plan B informing the company that it may … market Plan B without a prescription to women 17 years of age and older.”

Plan B is manufactured by Duramed Research, which was acquired by Teva Pharmaceutical Industries in December as part of its acquisition of Barr Pharmaceuticals.