USA FDA approves ANDAs for Plan B One-Step and Trandate

16 July 2012

Watson Pharmaceuticals (NYSE: WPI) says its subsidiary Watson Laboratories approval from the US Food and Drug Administration for its Abbreviated New Drug Application (ANDA) for Next Choice ONE DOSE (levonorgestrel Tablet, 1.5 mg), the generic equivalent to Teva Women's Health's Plan B One-Step. Watson plans to launch the product immediately.

For the 12 months ending May 31, 2012, Plan B One-Step had total US sales of around $88 million according to IMS Health data. 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.

Par Pharmaceutical gets nod for generic Trandate

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