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Merck, NDAC Chair Neill Cross Paths Again For Oxytrol Switch Meeting

This article was originally published in The Tan Sheet

Executive Summary

Nonprescription Drugs Advisory Committee member Richard Neill in 2007 praised Merck’s Rx-to-OTC application for Mevacor while voting against the statin switch. On Nov. 9, Merck will try to convince now-chairman Neill and the rest of NDAC that overactive bladder drug Oxytrol can safely be sold OTC.

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

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.

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

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.

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

In a 6-5 vote, FDA’s Nonprescription Drugs Advisory Committee said Merck did not 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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