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Pharma & Bio Ingredients
The analyst estimates the company booked around $40 million per year in Plan B sales, and expects the nonprescription clearance to raise that to about $49 million in the coming year with the approval. However, the approval is more symbolic than anything as Barr reported annual revenue of $1.31 billion for the fiscal year ended June 30.
Woodcliff Lake, N.J.-based Barr had sought nonprescription status for the drug from the FDA since 2003 but the approval process encountered many delays, causing some critics to allege the agency was stalling the approval over political concerns rather than scientific ones. Plan B was first approved by the FDA in 1999. Canadian regulators approved the prescription product in 2000 and the nonprescription product in 2002.
However, Uhl said the controversy significantly raised the profile of the pill.
"Every bit of publicity has helped make people more aware that it exists as potential choice," Uhl said in an interview.
The pill will be sold by Barr's Duramed Pharmaceuticals unit. The FDA nonprescription approval applies only to people 18 years or older; those 17 and younger will still need a prescription to obtain the pill.
Unlike a normal over-the-counter medication, Plan B is kept behind the counter and must be obtained directly from the pharmacist.
Proponents of the nonprescription version argued that since the pill must be used within 72 hours of having sex to be effective, scheduling an appointment with a doctor could result in missing that window since the pill does not terminate a pregnancy that has already started.
Because of the previous FDA delay, the states of Alaska, California, Hawaii, Maine, Massachusetts, New Hampshire, New Mexico, Vermont and Washington took matters into their own hands and allowed women to get access to the pill without a prescription. The FDA decision will not affect those states' pharmacy access arrangements.
Barr spokeswoman Carol A. Cox said Plan B retails for about $25 to $40 for a two-pill regimen. While the company has yet to set a price for the nonprescription version, Cox said it will "probably be slightly more" than the prescription version.
The company said the nonprescription version will be out before year-end, but Cox said that the release is likely to be sooner rather than later. The company needs to make new packaging for the pill so it can used as a prescription or a nonprescription version, the biggest difference being an adhesive label that goes on the package.
