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NDAC Puts Hitch In Oxytrol Switch With Negative Self-Selection Vote

This article was originally published in The Pink Sheet Daily

Executive Summary

In a 6-5 vote, FDA’s Nonprescription Drugs Advisory Committee said Merck failed to show that consumers can appropriately self-select to use Oxytrol for Women in an OTC setting. The company expects to hear from FDA on its Rx-to-OTC switch application by the end of January.

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