Generic “Morning After Pill” Earns FDA Approval for Girls Under 17

The Food and Drug Administration has just approved the first prescription-only version of Plan B, the so-called “morning after pill,” for girls ages 17 and under.

Levonorgestrel, the generic form of Plan B, will be available in 0.75 mg. tablets made by Watson Laboratories Inc. of Corona, Ca.

The FDA approval announced today affects only use of levonorgestrel in women under age 18. Generic forms of the drug will not be available to women 18 and older until August, when Duramed Pharmaceuticals Inc. loses its market exclusivity protection for the nonprescription uses of the generic form of the drug, the FDA said.

Plan B was first approved in the United States in 1999, and in 2006, it was made available without prescriptions to women ages 18 and older. However, women under age 18 still had to have prescriptions to get Plan B, which terminates existing pregnancies if taken within 72 hours of unprotected sex or in cases where a failure of contraceptive measures is suspected.

Earlier this year, the FDA approved marketing Plan B to girls ages 17 and under without prescriptions. A U.S. District judge had ordered the FDA to reconsider its earlier policy of requiring younger women to have prescriptions for Plan B.

While levonorgestrel is approved as an emergency contraceptive, it is not effective in terminating existing pregnancies and does not protect against sexually transmitted diseases, including HIV infection.

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