FDA approves Teva's OTC emergency contraceptive

Teva can now market its Plan B One-Step contraceptive pill in the US without a prescription to girls under 17.

The US Food and Drug Administration (FDA) has approved the emergency contraceptive Plan B One-Step, produced by Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) subsidiary Teva Women's Health, for over-the-counter sale to consumers of all ages in the US. Teva can now market its Plan B One-Step contraceptive pill without a prescription to girls under 17.

Teva said, "This landmark decision represents the continuation of improving access to emergency contraception to all who need it, when they need it."

“Bringing Plan B One-Stepout 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,” said Teva Global Women's Health SVP and general manager Jill DeSimone. “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. 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."

Teva added, "In the US the unintended pregnancy rate remains high; 49% of all pregnancies are unplanned. The fact that nearly half of the 3.1 million unintended pregnancies that occur in the US each year occur in women who reported taking contraception during the month they conceived emphasizes the need for increased access to emergency contraception. With Plan B One-Step, women can take an additional step to prevent an unintended pregnancy after contraceptive failure or unprotected sex."

Published by Globes [online], Israel business news - www.globes-online.com - on June 23, 2013

© Copyright of Globes Publisher Itonut (1983) Ltd. 2013

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