Watson receives FDA approval for Plan B generic
MORRISTOWN, N.J. Watson Pharmaceuticals on Friday announced that its subsidiary, Watson Labs, has received approval from the Food and Drug Administration regarding its abbreviated new drug application for levonorgestrel (the generic equivalent of Plan B) for over-the-counter use in women ages 17 and above, as well as for prescription use in women under the age of 17.
For the 12-months ended June 30, Plan B had total U.S. sales of approximately $135 million, Watson stated. Watson will market the product under the trade name Next Choice and plans to launch the product shortly.
On June 24, Watson received FDA approval of Next Choice for prescription use. Following this approval, Next Choice is now labeled for both prescription and over-the-counter use, similar to Plan B.