FDA grants exclusivity to Teva's Plan B contraceptive

WASHINGTON — The Food and Drug Administration has granted the manufacturer of Plan B One-Step exclusive marketing rights for three years, according to published reports.

According to the New York Times, the decision by the FDA sets Teva Pharmaceuticals as the only company able to sell the drug over-the-counter and without a prescription to a person of any age.

Generic versions of the pill are subject to regulatory approval from the FDA for permission to be sold on OTC shelves rather than from a pharmacy counter, but approval of the generic version does not allow the manufacturer to sell the drug to anyone under 17 until the three year exclusivity period ends.

In April, a District Court judge in New York ruled the FDA had 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages allowing the drug to finally make its way to store shelves.

 

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