The Food and Drug Administration has approved the emergency contraceptive Plan B One-Step for over-the-counter sale to all consumers in the United States.


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FDA clears OTC availability of Plan B One-Step

June 21st, 2013

NORTH WALES, Pa. – The Food and Drug Administration has approved the emergency contraceptive Plan B One-Step for over-the-counter sale to all consumers in the United States.

Teva Women's Health, a subsidiary of Teva Pharmaceutical Industries Ltd., on Friday said the "landmark decision" continues a trend of improving access to emergency contraception.

"Bringing Plan B One-Step out from behind the pharmacy counter helps women tremendously by removing one of the biggest barriers to access and timely use of emergency contraception, which is critically important. Plan B One-Step allows women to get what they need with one dose, without waiting 12 hours to take a second pill to complete the regimen," stated Jill DeSimone, senior vice president and general manager at Teva Global Women's Health.

"We are committed to ensuring Plan B One-Step is available to women who need it as it transitions into the aisle. As such, the price of Plan B One-Step to wholesale and retail outlets will remain unchanged," she added. "Plan B One-Step will also continue to be sold to hospitals and health clinics at a subsidized price for women who may not otherwise be able to afford it."

Plan B One-Step (levonorgestrel tablet 1.5 mg) is the first one-pill emergency contraceptive that will be available in store aisles with no age or point-of-sale restrictions, and it won't require consumers to show identification to buy it, Teva noted.

"At Teva, we are committed to ensuring information, educational tools and health care professional support are made available to all those who need it, right at the time that they need it," DeSimone commented.

In the United States, the unintended pregnancy rate remains high, with nearly half (49%) of all pregnancies are unplanned, Teva reported. The fact that almost half of the 3.1 million unintended pregnancies in the United States each year involve women who reported taking contraception during the month they conceived emphasizes the need for wider access to emergency contraception, the company noted.

"Teva, as well as women's health advocates and leading medical professionals, has worked for years to increase access to this time-sensitive product that is critically important to all women of reproductive age," stated Martin Berndt, vice president and general manager of U.S. brand pharmaceuticals for Teva Women's Health. "As is customary for any prescription to full over-the-counter switch, and as requested by the FDA, Teva completed a clinical study to support nonprescription marketing of Plan B One-Step. Teva is the only company that has conducted actual use and label comprehension studies required by the FDA, which show that women of all ages understand how to use Plan B One-Step."

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