Women's Health Weekly
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Contraception
FDA decision on Plan B OTC status delayed
February 24th, 2005
Barr Pharmaceuticals, Inc., (BRL) confirmed the U.S. Food and Drug Administration (FDA) has informed the company it would be unable to complete its review of the company's supplemental new drug application (sNDA) to market the Plan B (levonorgestrel) emergency contraceptive over-the-counter (OTC) by the January 21, 2005, Prescription Drug User Fee Act date. The FDA also indicated to the company that it is committed to completing its review of the application in the near future. The company remains optimistic the agency will approve Plan B for OTC sale. Plan B continues to be available to American consumers by prescription. The company's sNDA, if...
Source: Women's Health Weekly (2005-02-24)
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