FDA announces framework for moving Plan B OTC

August 7, 2006

The FDA announced it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B as an OTC contraceptive option. The agency and the sponsor will discuss the sponsor's proposed restricted distribution and risk management plan as part of the framework for potential approvability as a nonprescription product for women aged 18 and older.

FDA announces framework for moving Plan B OTC

The FDA announced it is proceeding to work with Duramed, a subsidiary of Barr Pharmaceuticals, to resolve the remaining policy issues associated with the marketing of Plan B as an OTC contraceptive option. The agency and the sponsor will discuss the sponsor's proposed restricted distribution and risk management plan as part of the framework for potential approvability as a nonprescription product for women aged 18 and older. The FDA issued a statement that said, "The agency hopes both sides are committed to working diligently through these issues so the process can be wrapped up in a matter of weeks." The FDA's announcement was made on July 31, the day before Andrew von Eschenbach's nomination hearing for the position of FDA commissioner.

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