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.
One study linked multiple pregnancies to an increased risk of developing atrial fibrillation later in life, and another investigated the association between premature delivery and cardiovascular disease.
Clinical features with downloadable PDFs