FDA Approves Generic Prescription-Only Version Of Plan B Emergency Contraceptive For Women Ages 17 And Under

The U.S. Food and Drug Administration approved the first generic version of the emergency contraceptive Plan B (levonorgestrel) tablets, 0.75 mg. 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 only for women of all ages. Plan B is manufactured by Duramed Pharmaceuticals Inc., of Cincinnati.

In 2006, Plan B was approved for nonprescription use for women ages 18 and older. Plan B remained available as a prescriptiononly product for women ages 17 and under. Todays approval allows marketing of a prescriptiononly generic product for women ages 17 and under. No generic levonorgestrel product for emergency contraception can be approved for nonprescription use in women ages 18 and older until Aug. 24, 2009, when the marketing exclusivity held by Duramed for the nonprescription use expires.

The generic levonorgestrel tablets 0.75 mg are made by Watson Laboratories Inc., based in Corona, Calif.

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This entry was posted on Jueves, Junio 25th, 2009 at 22:00 and is filed under womens health. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.

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