FDA Approves Generic Version of Plan B Emergency Contraceptive
Plan B, which is manufactured by Duramed Pharmaceuticals Inc., was first approved in 1999. Women of all ages were able to access Plan B by prescription only. In 2006, Plan B was approved for non-prescription use for women ages 18 and older. However, Plan B still remained available as a prescription- only product for women ages 17 and under. Today’s approval allows marketing of a prescription-only generic product for women ages 17 and under. No generic Levonorgestrel product for emergency contraception can be approved for non-prescription use in women ages 18 and older until August 24, 2009, when the marketing exclusivity held by Duramed Pharmaceuticals for the non-prescription use expires.
For additional information see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm168870.htm