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Teva endocrine/metabolic news

March 19, 2012 7:00 AM UTC

Teva filed a motion to intervene in the Center for Reproductive Rights' suit against FDA that is seeking unrestricted OTC access to all levonorgestrel-based emergency contraceptives, including Teva's Plan B One-Step and generics. The contraceptives are approved for OTC use only in women 17 years and older. Teva said the center's request for unrestricted OTC access to all emergency contraceptives would threaten its right to three years of exclusivity for unrestricted OTC sales of its Plan B. Teva said it earned the right by submitting an sNDA to FDA containing clinical studies for the OTC use. ...