Watson Pharmaceuticals Inc granted FDA approval for generic PLAN B
WPI | Quote | Chart | News | PowerRating -- 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.
Watson noted that PLAN B's over-the-counter new product exclusivity
expires on 24 August 2009.
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