FDA approves Plan B One-Step for all women of reproductive potential without a prescription
The U.S. Food and Drug Administration (FDA) announced Thursday it’s approval of Plan B One-Step (levonorgestrel) as a nonprescription product for all women of child-bearing potential.
This approval comes after the agency’s June 10th notification of a United States District Court judge in New York of its intent to comply with the court’s April 5, 2013 order instructing the FDA to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions.
To comply, the FDA asked Teva Women’s Health, the manufacturer of Teva , to submit a supplemental application seeking approval of the one-pill product to be made available without any restrictions. The agency has fulfilled its commitment to the court by promptly completing its review and approval of the supplemental application.
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