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The dual-status Rx/OTC version of Plan B (levonorgestrel) is now available in pharmacies. Duramed Pharmaceuticals Inc, a wholly owned subsidiary of Barr Pharmaceuticals, began shipping the medication in mid November.
The dual-label product is approved for OTC sale for women aged 18 and older. The Plan B OTC/Rx version will be marketed as a single package, which will allow for an Rx label to be affixed to the package when dispensed to girls aged 17 and younger. Because Plan B remains a prescription product for adolescents, it will be available only in retail pharmacy outlets from behind the counter and under the supervision of a pharmacist.
The FDA granted Duramed 3-year exclusivity for Plan B, based on clinical studies conducted for OTC approval. The exclusivity is valid until August 2009.
Visit ePharmacy Times at www.pharmacytimes.com/articleNewsletter.cfm?OD=4023 for a related story on Plan B.