FDA Approve One-Pill Version Of Plan B, Sets Over-The-Counter Access At Age 17

Main Category: Women's Health / Gynecology
Also Included In: Sexual Health / STDs;  Regulatory Affairs / Drug Approvals;  Pediatrics / Children's Health
Article Date: 14 Jul 2009 - 2:00 PDT

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FDA approved Teva Pharmaceuticals' Plan B One-Step -- a single-pill version of the two-pill dose emergency contraceptive product Plan B -- and lowered the limit for over-the-counter purchase of the drug to age 17, the company announced on Monday, the AP/Yahoo! Finance reports (AP/Yahoo! Finance, 7/13). Individuals ages 16 and younger will be required to obtain prescriptions to purchase Plan B, which reduces the chance of pregnancy when taken within 72 hours of sexual intercourse (Teva Pharmaceuticals release, 7/13).

Teva said the one-pill version will be available at retail pharmacies in August (AP/Yahoo! Finance, 7/13). Kelli Conlin, president of the National Institute for Reproductive Health, said, "Health care 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" (Teva Pharmaceuticals release, 7/13).

The expanded access to the medication comes several months after a federal court lifted restrictions put in place under former President George W. Bush that limited OTC sales to women ages 18 and older (AP/Yahoo! Finance, 7/13).

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