FDA OKs Single-Dose Plan B Emergency Contraceptive
MONDAY, July 13 -- A single-pill version of the Plan B emergency contraceptive has been approved by the U.S. Food and Drug Administration. The drug previously was available in a two-pill dose.
The new Plan B One-Step will be available at pharmacies in August, Teva Pharmaceutical Industries Ltd. said Monday.
The FDA also said it expanded over-the-counter access to Plan B One-Step to consumers over 17 years old, while those younger than 17 will require a prescription. Previously, OTC sales were limited to women aged 18 and older.
Plan B reduces the chance of pregnancy when taken within 72 hours (three days) of unprotected sex or contraceptive failure. The sooner the drug is taken, the more effective it is, according to Teva. Plan B won't work if a woman is already pregnant and will not terminate an existing pregnancy.
The approval of Plan B One-Step is a "milestone" in women's health, said Kelli Conlin, president of the National Institute for Reproductive Health. "Healthcare providers and women's advocates have been eager for a one-pill emergency contraceptive for years and are happy to see it finally come to fruition," Conlin said in a news release.
The U.S. National Women's Health Information Center has more about emergency contraception.
Posted: July 2009