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Teva Gets FDA Approval for New Version of Plan B

By Pharmaceutical Processing | July 13, 2009

NEW YORK (AP) — Teva Pharmaceutical Industries Ltd. said Monday the FDA approved the company’s one-pill version of the emergency contraceptive Plan B. The drug has been available in a two-pill dose. Teva said the new Plan B will be available at retail pharmacies in August. The FDA, meanwhile, has expanded over-the-counter access to consumers over 17 years old. Women younger than 17 require a prescription. The expanded access comes months after a federal court’s order lifting Bush administration restrictions limiting over-the-counter sales of Plan B to women 18 and older. The drug is meant to be taken within 72 hours of sex to reduce the chance of pregnancy. During the first quarter, the company said sales in the women’s health business jumped 39 percent to $97 million, primarily attributable to sales of Plan B. The women’s health business was part of the Barr Pharmaceutical buyout. Teva’s net sales in the first quarter reached $3.15 billion.

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