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FDA Approves Over-the-Counter Availability Of Plan B One-Step® (levonorgestrel) For All Consumers

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.

“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,” said Martin Berndt, Vice President & General Manager, U.S. Brand Pharmaceuticals, Teva Women’s Health, Inc. “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 non-prescription 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 ®.”

Consumers can learn more about Plan B One-Step ® by visiting www.PlanBOneStep.com, where they can get reliable information about the product and when it should be taken, and review answers to frequently asked questions. There is also a toll-free hotline (1-800-330-1271) where consumers can talk live to a healthcare professional.

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. Plan B One-Step ® 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. For additional information, visit www.PlanBOneStep.com.

Plan B One-Step ® (levonorgestrel) is intended to prevent pregnancy after known or suspected birth control failure or unprotected sex.

About Teva Women’s Health, Inc.

Teva Women’s Health, Inc. is a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: TEVA), headquartered in Israel. The company produces a wide range of women’s healthcare products including oral contraceptives, intrauterine contraception and hormone therapy treatments for menopause and perimenopause. Teva Women’s Health, Inc. maintains a strong commitment to enhancing women’s lives by actively pursuing new areas of research and providing distinct pharmaceutical options that meet women’s needs and fit their lifestyles. Through close engagement with women and healthcare providers, the company maintains an in-depth understanding of the important health matters that affect women.

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