Generic Plan B Contraceptive Approved For Teens

Approved For Teens Under 17

The Food and Drug Administration (FDA) has approved the first generic version of the Plan B by prescription for women ages 17 and under.

Plan B as the morning-after-pill is known, was first approved in 1999 for women of all ages by prescription use only. Duramed Pharmaceuticals Inc. of Cincinnati is the maker.

In 2006, nonprescription use was approved for women ages 18 and older and available for younger women by prescription only.

Wednesday’s approval will allow a generic product for women ages 17 and under by prescription only. The generic version for women 18 and older for nonprescription use, will be available after August 24, when Duramed’s marketing exclusivity for nonprescription Plan B expires.

Watson Pharmaceuticals of Corona, California, has received Food and Drug Administration (FDA) approval for the generic version, which will be known as “Next Choice”.

The generic version (levonorgestrel 0.75 mg), if taken within 72 hours of intercourse reduces the risk of pregnancy. It does not protect against sexually transmitted disease, HIV, and does not terminate a pregnancy.

The Bush administration had imposed an 18-year-old age limit for use of Plan B. In March, a federal court directed the FDA to permit Plan B be made available to women 17 and older, without a prescription,

Last April, a Federal court decided the FDA restriction was based on politics and not science. The FDA okayed sales to teenagers 17 and younger, over-the-counter without a prescription, according to the FDA.

In a statement, Cecile Richards, president of Planned Parenthood Federation of America, called the announcement "a strong statement to American women that their health comes before politics."

"This decision is commonsense policy that will help reduce the number of unintended pregnancies and protect the health and safety of all women," she said to MedPage Today.