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news.Watson Laboratories, a subsidiary of Watson Pharmaceuticals, has gained FDA abbreviated new drug application (ANDA) approval for Next Choice ONE DOSE (Levonorgestrel Tablet, 1.5mg).
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The Next Choice ONE DOSE (Levonorgestrel Tablet, 1.5mg) is the generic equivalent to Teva Women’s Health’s Plan B One-Step. The company plans to launch the product immediately.
Plan B One-Step is a progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure.
According to IMS Health data, Plan B One-Step had total US sales of approximately $88m for the twelve months ending 31 May 2012.
Watson Pharmaceuticals, an integrated global specialty pharmaceutical company, is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on urology and women’s health.