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Teva's Plan B One-Step Trips As Watson's Generic Gains Market Share

This article was originally published in The Tan Sheet

Executive Summary

Sales ofPlan B One-Step are taking a substantial hit from generic levonorgestrel despite the product's single-dose formulation and Teva Pharmaceutical Industries' aggressive marketing

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FDA Analysis Finds Plan B Safe For Children

FDA found only 13 reports of serious pediatric AERs following ingestion of original two-dose Plan B or one-dose Plan B One-Step. In a review released Jan. 27, Office of Surveillance and Epidemiology officials said the data do not causally link the majority of pediatric AERs definitively to the drug.

FDA Analysis Finds Plan B Safe For Children

FDA found only 13 reports of serious pediatric AERs following ingestion of original two-dose Plan B or one-dose Plan B One-Step. In a review released Jan. 27, Office of Surveillance and Epidemiology officials said the data do not causally link the majority of pediatric AERs definitively to the drug.

Teva's Plan B One-Step OTC Application Puts FDA On The Spot

Teva Pharmaceutical Industries asks FDA to allow over-the-counter sales of Plan B One-Step, starting the likely final leg of the emergency contraceptive's journey toward OTC status.

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