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Plan B One-Step Goes OTC, With Three-Year Exclusivity, Lower Age Limit

 
• By Malcolm Spicer

FDA approved Plan B One-Step to be sold in some OTC venues to women 15 and older, lowering the age restriction and moving the product out from behind pharmacy counters. Teva Women’s Health gets three years of exclusivity for the product, based on studies of label comprehension among women as young as 15.

Teva Women's Health Inc. gains three years of OTC market exclusivity for Plan B One-Step with FDA’s April 30 approval of the firm’s proposal to make the product available to consumers 15 and older, in a qualified form of OTC sale.

Plan B One-Step (levonorgestrel 1.5 mg), the second generation of the original two-dose Plan B (levonorgestrel 0.75 mg), had market...

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