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Dual Status Rx/OTC Plan B In The Works? Barr Weighs Its Options

This article was originally published in The Tan Sheet

Executive Summary

Barr hinted that it is leaning toward a dual label Rx/OTC approach in seeking FDA approval to switch the Plan B "morning after" pill

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FDA “Unable” To Decide On Plan B, Seeks Comment On Dual-Status Drugs

FDA believes additional information on whether a drug can be marketed both Rx and OTC for the same indication is needed before a decision can be reached on Barr Labs' switch application for Plan B

FDA “Unable” To Decide On Plan B, Seeks Comment On Dual-Status Drugs

FDA believes additional information on whether a drug can be marketed both Rx and OTC for the same indication is needed before a decision can be reached on Barr Labs' switch application for Plan B

FDA “Unable” To Decide On Plan B, Seeks Comment On Dual-Status Drugs

FDA believes additional information on whether a drug can be marketed both Rx and OTC for the same indication is needed before a decision can be reached on Barr Labs' switch application for Plan B

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