The dual-status Rx/OTC version ofPlan B (levonorgestrel) is now availablein pharmacies. Duramed PharmaceuticalsInc, a wholly owned subsidiaryof Barr Pharmaceuticals, beganshipping the medication in midNovember.
The dual-label product is approvedfor OTC sale for women aged18 and older. The Plan B OTC/Rx versionwill be marketed as a singlepackage, which will allow for an Rxlabel to be affixed to the packagewhen dispensed to girls aged 17 andyounger. Because Plan B remains aprescription product for adolescents,it will be available only inretail pharmacy outlets from behindthe counter and under the supervisionof a pharmacist.
The FDA granted Duramed 3-yearexclusivity for Plan B, based on clinicalstudies conducted for OTC approval.The exclusivity is valid untilAugust 2009.
Visit ePharmacy Times at www.pharmacytimes.com/articleNewsletter.cfm?OD=4023 for a related story onPlan B.