Duramed's emergency contraceptive moves toward over-the-counter status

By Elaine Rigoli

Tampa, Fla., July 31 - The Food and Drug Administration said Monday that it is working with Duramed to resolve the remaining policy issues associated with the marketing of Plan B as an over-the-counter option.

The FDA is working on a proposed restricted distribution and risk-management plan as part of the framework for potential approvability as a non-prescription product for women ages 18 and older.

Plan B contains an ingredient used in prescription birth control pills, only in the case of Plan B, each pill contains a higher dose and the product has a different dosing regimen. Like other birth control pills, Plan B is available as a prescription drug.

Duramed, a subsidiary of Barr Pharmaceuticals, is a specialty pharmaceutical company based in Woodcliff Lake, N.J.

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