US FDA clears Barr's Plan B for OTC use

The USA's Barr Pharmaceuticals says that the Food and Drug Administration has approved its supplemental New Drug Application to market its Plan B (levonorgestrel) emergency contraceptive over the counter, allowing it to be sold without a prescription.

In approving the sNDA, the agency granted OTC status for consumers 18 years of age and older, while maintaining the prescription status for women 17 and younger. Barr's subsidiary Duramed plans to introduce the dual status OTC/prescription version of the product before the end of the calendar year. Industry observers noted that while the approval will increase the product's annual sales from the present $40.0 million to $80.0 - $100.0 million, they added that this will hardly affect the firm's overall performance. Barr earned $1.3 billion in fiscal 2006. On the day the FDA announced its decision, August 24, shares in the New Jersey-headquartered firm fluctuated, falling $0.20 to close at $57.77, then rising $0.28 in trading on INET.