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

This article was originally published in The Tan Sheet

Executive Summary

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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Teva Opposes Switching Asthma Drugs, Oral Contraceptives

The firm’s opposition to allowing innovative switches for asthma drugs and oral contraceptives focuses on safety and consumers’ ability to self-select and manage their allergies or reproductive status, but maintains that Plan B One-Step and other emergency contraceptives are appropriate for full OTC status.

Teva Opposes Switching Asthma Drugs, Oral Contraceptives

The firm’s opposition to allowing innovative switches for asthma drugs and oral contraceptives focuses on safety and consumers’ ability to self-select and manage their allergies or reproductive status, but maintains that Plan B One-Step and other emergency contraceptives are appropriate for full OTC status.

Teva Plan B OTC Application Fails Political Test After Clearing FDA Hurdle

HHS Secretary Sebelius says Teva must show more evidence of how young adolescent females would use Plan B One-Step as an OTC. But obtaining such clinical data for the emergency contraceptive – in excess of what FDA already needed to approve it – appears nearly impossible, experts say.

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