Published On: Sun, Jun 23rd, 2013

Teva: FDA Approves Over-the-Counter Availability of one pill emergency contraceptive

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/By Ilan Shavit /

Teva Women’s Health, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has approved the emergency contraceptive Plan B One-Step® (levonorgestrel) tablet 1.5 mg for over-the-counter sale to all consumers in the United States.

Plan B One-Step® is the first one pill emergency contraceptive that will be available in store aisles with no age or point-of-sale restrictions, and will not require consumers to show identification in order to purchase it.

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 Jill DeSimone, Senior Vice President & General Manager, Teva Global Women’s Health.

The price of Plan B One-Step® to wholesale and retail outlets will remain unchanged, and 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.”

In the U.S., the unintended pregnancy rate remains high; nearly half (49%) of all pregnancies are unplanned. The fact that nearly half of the 3.1 million unintended pregnancies that occur in the U.S. 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.

About Plan B One-Step®

Plan B One-Step® is a progestin-only emergency contraceptive that can help prevent pregnancy after birth control failure or unprotected sex. When taken within 72 hours (three days) after birth control failure or unprotected sex, Plan B One-Step® can help prevent a pregnancy from occurring in about seven of eight women who would have become pregnant otherwise. Plan B One-Step® is not an abortifacient and will not harm an existing pregnancy. It is a back-up method of preventing pregnancy, but it isn’t regular birth control and should not be used that way, as it is not as effective as regular birth control methods used correctly.

 

 

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