Teva Women's Health Inc. has been cleared by the Food and Drug Administration to market Plan B One-Step emergency contraceptive tablets over the counter to women ages 15 and older.

Teva Women's Health, Plan B One-Step, emergency contraceptive, over the counter, Food and Drug Administration, FDA, levonorgestrel tablets, Teva Pharmaceutical Industries, Marty Berndt, Ashlesha Patel, M.D., Cook County Health & Hospitals System, Feinberg School of Medicine, birth control

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Teva OK'd to market Plan B One-Step on store shelves

May 1st, 2013

NORTH WALES, Pa. – Teva Women's Health Inc. has been cleared by the Food and Drug Administration to market Plan B One-Step emergency contraceptive tablets over the counter to women ages 15 and older.

The Teva Pharmaceutical Industries Ltd. U.S. subsidiary said late Tuesday that the FDA approval marks the first time that an emergency contraceptive will be available on store shelves and signals the improving access to emergency contraception for women.

Plan B One-Step (levonorgestrel tablets 1.5 mg) will now transition from behind the pharmacy counter to retail outlets with an on-site pharmacy, where it generally will be available in the family planning or women's health aisles, according to Teva. The product will be available for sale during the retailer's normal operating hours whether the pharmacy is open or not, the company added.

"For the past decade, emergency contraception has been available to millions of women to reduce the chance of an unplanned pregnancy following birth control failure or unprotected sex," stated Marty Berndt, vice president and general manager of U.S. brand pharmaceuticals for Teva Women's Health. "Today, we welcome the FDA's decision to provide extended and improved access to this important product, a significant milestone for women."

Teva said Plan B One-Step will now be labeled "Not for sale to those under 15 years of age. Proof of age required. Not for sale where age cannot be verified."

"This decision allows stores to place Plan B One-Step directly on store shelves so that women have immediate access to emergency contraception when they need it most to help reduce their chance of unintended pregnancy," commented Ashlesha Patel, M.D., system director of family planning services of Cook County Health & Hospitals System and associate professor at the Feinberg School of Medicine at Northwestern University in Chicago. "Providing easier access to emergency contraception will allow women greater control over their reproductive health and family planning goals."

Teva noted that age verification continues to be a key requirement with emergency contraception products. Similar to the processes that have been in place since the original prescription-to-OTC switch of Plan B tablets in 2006, strict age verification procedures will be followed at retail, according to the company.

Measures to ensure the appropriate sale of Plan B One-Step will follow the procedures in place for the control of the sale of nicotine-containing products at retail, Teva explained. Those include a UPC code that when scanned by a cashier will trigger an automatic message prompting them to request proof of age from the customer and to verify age. If age-verification cannot be performed, or if the intended customer does not meet the age requirement, the sale cannot proceed. Also, all product cartons will include a security tag as well as a hard-plastic shell design for added security to reduce the possibility of theft, the company added.

Plan B One-Step can be used up to 72 hours after birth control failure or unprotected sex to help decrease the chance of becoming pregnant.

Teva reported that the U.S. unintended pregnancy rate remains high, with 49% of all pregnancies unplanned. The company noted that nearly half of the 3.1 million U.S. unintended pregnancies each year are in women who reported taking contraception during the month they conceived, underscoring the need for increased access to emergency contraception.