Generic EBC "Next Choice" is Now Over-the-Counter
Watson Laboratories, Inc., has received approval from the US 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. 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 this approval, Next Choice(TM) is now labeled for both prescription and over-the-counter use.
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