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New Emergency Contraception Developments
One-dose formulation is approved; two-dose formulation goes generic.
The FDA has approved a single-dose formulation of the emergency contraceptive pill (ECP). Plan B One-Step, a single tablet that contains 1.5 mg of levonorgestrel, is expected to be generally available in retail pharmacies in August 2009. The original EC product, Plan B, consists of two 0.75-mg levonorgestrel tablets taken 12 hours apart. Like its predecessor, Plan B One-Step will be available without prescription (but behind the counter) for women 17 and older and by prescription only for women younger than 17. The FDA also recently approved Next Choice, a generic version of the two-dose levonorgestrel ECP product. This drug is now available by prescription only for women younger than 17 and is expected to be available to women 17 and older without prescription after the Plan B patent expires in late August.
Comment: The single-dose ECP formulation will simplify use, thereby possibly improving ECP effectiveness. Although the wider availability and accessibility of EC in the U.S. has not lowered unintended pregnancy rates overall, it has undoubtedly made a difference for individual women. Moreover, availability of EC has not compromised use of more-effective regular contraceptive methods, nor has it promoted sexual risk taking (JW Womens Health Mar 26 2009). Generic ECPs should lower the cost barrier enough that more women will be able to purchase them: Plan B and Plan B One-Step cost US$45 to $50, and Next Step is priced about $10 less. Most retail pharmacies that advertise $4 generic medications have not yet added generic ECPs to that program.
Published in Journal Watch Women's Health July 23, 2009
Citation(s):
Plan B One-Step — New FDA-approved one-pill emergency contraceptive: Single-dose formulation can be taken right away [press release]. North Wales, PA: Teva Pharmaceuticals, Inc.; Jul 10 , 2009. (http://planbonestep.com/pdfs/PlanBOneRelease_FINAL.pdf)
Plan-B One-Step [package insert]. Budapest, Hungary: Gedeon Richter, Ltd., for Duramed Pharmaceuticals, Inc.; 2009. (http://tinyurl.com/lopxp6)
FDA approves generic prescription-only version of Plan B emergency contraceptive for women ages 17 and under [press release]. Silver Spring, MD: Food and Drug Administration; Jun 24 , 2009. (http://tinyurl.com/n7amau)
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