The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Plan B OTC

The FDA’s press release on Plan B, which will soon be available OTC for women 17 and older.  The original FDA decision-making process for OTC Plan B was a multi-year ordeal.  This round was short and sweet:

“On March 23, 2009, a federal court issued an order directing the FDA, within 30 days, to permit the Plan B drug sponsor to make Plan B available to women 17 and older without a prescription. The government will not appeal this decision. In accordance with the court’s order, and consistent with the scientific findings since 2005 by the Center for Drug Evaluation and Research, FDA sent a letter to the manufacturer of Plan B that the company may, upon submission and approval of an appropriate application, market Plan B without a prescription to women 17 years of age and older.”

 

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