FDAnews
www.fdanews.com/articles/71663-plan-b-gets-otc-status-in-canada

Plan B Gets OTC Status in Canada

April 28, 2005

Barr Pharmaceuticals has received approval in Canada to sell its emergency contraceptive Plan B without a prescription.

Plan B (levonorgestrel) has been approved in Canada since 2000, but this is the first time it will be available directly from Canadian pharmacists without a prescription, Barr said. The company filed an application with Canada Health in 2002 to make Plan B available OTC.

Canada's approval could put even more pressure on the FDA to make a decision on the drug. The agency has come under heavy fire in recent weeks for dragging its feet on the drug, which Barr wants to make available without a prescription in the U.S. to women 16 years of age and older.