Plan B will be available over-the counter to women over the age of 18, and will still be prescription-only for women 17 and younger. The new version replaces Barr’s prescription-only Plan B which has been marketed in the US since 1999.
Bruce Downey, Barr’s chairman and CEO, said: “The FDA’s historic decision to enable us to provide Plan B without a prescription for consumers 18 and older will now remove a medically unnecessary requirement that had served as a barrier to timely access.”
Barr said that the FDA had also granted the company a three-year exclusivity for its Plan B product, based on clinical studies, that is valid until August 2009.