Speciality pharmaceutical company Watson Pharmaceuticals Inc (NYSE: WPI) reported on Wednesday that its subsidiary Watson Laboratories Inc has been granted approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for levonorgestrel tablets.
Levonorgestrel (0.75 mg), which is the generic equivalent to Duramed Pharmaceuticals' PLAN B, is indicated for the prevention of pregnancy following unprotected intercourse or contraceptive failure. This product is indicated for girls aged 17 years and younger is approved for prescription use only.
The company plans to market and launch the product shortly under the trade name Next Choice.
PLAN B, for the 12 months ending March 2009,Arecorded total US sales of approximately USD123m, of which approximately 10% are attributable to prescription sales, according to IMS sales data.
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