Watson Pharmaceuticals granted FDA approval for generic PLAN B for over-the-counter use
WPI | Quote | Chart | News | PowerRating -- Pharmaceutical company Watson Pharmaceuticals Inc (NYSE:WPI) reported
on Friday that its subsidiary Watson Laboratories Inc has received US
Food and Drug Administration (FDA) approval for its Abbreviated New
Drug Application (ANDA) for Levonorgestrel Tablets, 0.75 mg for
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 reportedly the generic equivalent to
Duramed Pharmaceuticals' PLAN B (Rx/OTC), which is indicated for the
prevention of pregnancy following unprotected intercourse or
contraceptive failure.
PLAN B had total US sales of approximately USD135m for the 12 months
ending 30 June 2009.
Watson intends to market the product under the trade name Next Choice
and proposes to launch it shortly.
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