Last week, the FDA approved the first generic emergency contraception pill, known as levonorgestrel. The drug will be available to women ages 17 and older beginning Aug. 24, 2009, when Plan B’s over-the-counter patent protection expires.
This news marks considerable progress in broadening women’s access to affordable emergency contraception; even though the FDA said last April that it would allow over-the-counter sales of Plan B to women age 17 or younger, in reality, women under 18 still do not have access to the drug. From MedPage Today:
…when the FDA said it would allow OTC sales of Plan B to 17 year-olds it meant that the FDA would allow the drugmaker — Duramed Pharmaceuticals of Cincinnati — to submit an application for OTC use by 17-year-olds.
As an FDA employee, [Siobhan DeLancey, who wrote the FDA press release announcing approval of generic Plan B] couldn’t say whether or not Duramed had submitted such an application, but she could say that no application for OTC sales to 17-year-olds has been approved.
Thus, the only way a 17-year-old can acquire the drug — whether brand name or generic — is with a prescription.
Watson Pharmaceuticals, the company who produces the generic levonorgestrel tablet, plans to market the drug under the name “Next Choice” and “launch the product shortly.”