FDA approves Plan B One-Step emergency contraceptive for OTC use by women of child-bearing potential

21 June 2013

The US Food and Drug Administration has approved the use of Plan B One-Step (levonorgestrel), from Israel-headquartered Teva Pharmaceutical Industries (NYSE: TEVA) as a non-prescription product for all women of child-bearing potential. This action complies with the April 5, 2013 order of the US District Court in New York to make levonorgestrel-containing emergency contraceptives available as an over-the-counter (OTC) product without age or point-of-sale restrictions.

Plan B One-Step is an emergency contraceptive intended to reduce the chance of pregnancy following unprotected sexual intercourse or a known or suspected contraceptive failure (eg, condom). Plan B One-Step is a single-dose pill (1.5mg tablet) that is effective in decreasing the chance of pregnancy and should be taken as soon as possible within three days after unprotected sex.

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