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FDA approves generic version of Plan B
The FDA said the generic product will be available by prescription only for women ages 17 and under.
Plan B was first approved in 1999 for prescription use for women of all ages. In 2006, Plan B was approved for non-prescription use for women ages 18 and older while still available as a prescription-only product for women ages 17 and under.
The FDA's Wednesday approval allows marketing of a prescription-only generic product for women ages 17 and under. The federal agency said no generic levonorgestrel product for emergency contraception can be approved for non-prescription use in women ages 18 and older until Aug. 24 when the marketing exclusivity for non-prescription use expires.
Generic levonorgestrel tablets 0.75 milligram are made by Watson Laboratories Inc. of Corona, Calif.
Plan B is manufactured by Duramed Pharmaceuticals Inc. of Cincinnati.
Copyright 2009 by United Press International
This news arrived on: 06/24/2009
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