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FDA approves generic contraceptive pill

6/24/2009

ROCKVILLE, Md. The Food and Drug Administration has approved a generic version of a popular contraceptive pill.

The FDA announced Wednesday that it had approved Watson Labs’ levonorgestrel tablets in the 0.75-mg strength, a generic version of Duramed Pharmaceuticals’ Plan B contraceptive pill. The generic version will be available by prescription only for girls ages 17 and younger.

The FDA approved Plan B in 2006 for women ages 18 and older without a prescription, but it remained available only by prescription for girls younger than 18. The FDA also is barred from approving a nonprescription generic version of Plan B for adult women until Aug. 24, when Duramed’s marketing exclusivity for the nonprescription use of Plan B expires.

The drug prevents pregnancy after unprotected sex, or if a contraceptive has failed.

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