Teva was awarded three years of market exclusivity by the FDA for Plan B One-Step (levonorgestrel), making it the only emergency contraceptive that can be sold to women or girls without a prescription. The announcement follows a decision by the agency to comply with the April ruling of US District Court Judge Edward Korman to allow emergency contraceptives to be made available without age or point-of-sale restrictions.
Korman had warned the agency not to enter into an exclusivity agreement with Teva, citing concerns that such an agreement could make the contraceptive unaffordable for some patients. However, FDA spokesperson Erica Jefferson said the decision to grant exclusivity comes after it was determined the company supplied the only research data supporting the safe over-the-counter use of emergency contraceptives. Korman permitted the FDA to determine whether to continue to restrict access to two-pill versions of oral contraceptives.
Last month, the FDA approved Plan B as an emergency contraceptive for women of all ages, and the product began to arrive at drugstores this week.
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