FDA Approves Generic Prescription-Only Version of Plan B for 17 and Under
The FDA has approved the first generic version of emergency contraceptive Plan B for women 17 and under, with a prescription. The approval follows a federal court order that the FDA lower the age limit of Plan B to 17. The FDA did not appeal the ruling, but required Plan B’s maker, Duramed Pharmaceuticals Inc., to file an application first.
The generic product is not yet available for use without a prescription because Duramed has a patent on Plan B’s nonprescription sales until Aug. 24, 2009. Watson Laboratories, a different company, makes the new generic product, and will have to seek approval from the FDA after Duramed’s patent expires. The FDA has not disclosed whether Watson has already filed an application.
The contraceptive was first approved in 1999 for prescription use only for women of all ages. In 2006, it was approved for nonprescription use in women aged 18 and older. Levonorgestrel can reduce the risk of pregnancy if taken after unprotected intercourse or contraceptive failure. The drug cannot terminate an existing pregnancy and does not protect against sexually transmitted infections, according to the FDA.