Teva Women's Health, Inc., a U.S.-based subsidiary of Teva Pharmaceutical Industries Ltd. (TEVA), said Tuesday that the U.S. Food and Drug Administration has approved the emergency contraceptive Plan B One-Step tablet 1.5 mg for over-the-counter sale to consumers 15 years of age and older in the United States.
The decision marks the continuation of improving access to emergency contraception for women and is the first time that an emergency contraceptive will be available in the store aisle.
Plan B One-Step will now transition from behind the pharmacy counter to retail outlets with an onsite pharmacy, where it generally, will be available in the family planning or female health aisles. The product will be available for sale during the retailer's normal operating hours whether the pharmacy is open or not.
The product 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". Age verification continues to be an important requirement with emergency contraception products. Similar to the processes that have been in place since the original prescription to over-the-counter switch of Plan B tablets in 2006, strict age verification procedures will be followed at retail.
For comments and feedback: editorial@rttnews.com