Published on August 29, 2009 at 12:18 AM
Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its subsidiary, Watson Laboratories, Inc., has received approval today from the United States Food and Drug Administration (FDA) on its Abbreviated New Drug Application (ANDA) for Levonorgestrel Tablets, 0.75 mg for over-the-counter use in women ages 17 and above, as well as for prescription use in women under the age of 17. Levonorgestrel Tablets, 0.75 mg is the generic equivalent to Duramed Pharmaceuticals' PLAN B(R) (Rx/OTC), which is indicated for the prevention of pregnancy following unprotected intercourse or contraceptive failure. For the 12-months ending June 30, 2009, PLAN B(R) had total U.S. sales of approximately $135 million. Watson will market the product under the trade name Next Choice(TM) and plans to launch the product shortly.
On June 24, 2009, Watson received FDA approval of Next Choice(TM) (levonorgestrel) Tablets, 0.75 mg for prescription use. Following today's approval, Next Choice(TM) is now labeled for both prescription and over-the-counter use.
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