Friday, Watson Pharmaceuticals, Inc. (WPI), a specialty pharmaceutical company, said that its subsidiary, Watson Laboratories, Inc., has received approval from the Food and Drug Administration or FDA on its Abbreviated New Drug Application or ANDA for Levonorgestrel Tablets, over-the-counter use in women aged 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 for prevention of pregnancy. For the 12-months ending June 30, 2009, Plan B had total U.S. sales of around $135.0 million. Watson will market the product under the trade name Next Choice and plans to launch the product shortly.
Two months ago, Watson received FDA approval of Next Choice Tablets, 0.75 mg for prescription use. Following FDA's approval, Next Choice is now labeled for both prescription and over-the-counter use.
On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit Plan B drug sponsor to make Plan B available to women aged 17 and older without a prescription over the counter. In accordance with the court's order, and consistent with the scientific findings made in 2005 by the Center for Drug Evaluation and Research, FDA notified the manufacturer of Plan B that it may, upon submission and approval of an appropriate application, market Plan B without a prescription to women aged 17 years and older.
WPI closed Friday's regular trading at $35.35, up $0.33 or 0.94%, on a volume of 0.896 million shres on the NYSE. In after hours, the stock gained $0.11 or 0.31%, trading at $35.46.
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