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

This article was originally published in The Tan Sheet

Executive Summary

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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In Brief: NAD trims BPI claims, formula price-fixing in China, FDA warns Formulife and identifies spiked supplements, NBTY’s consumer redress

BPI discontinues claims at NAD’s behest; China levies fines for infant formula price-fixing; Public Citizen pans OTC Oxytrol; FDA advises ProNatural supplements cannot be topical; FDA warns Formulife on DMAA; FDA uncovers more spiked supplements; NBTY pays back consumers over omega-3 claims; Algean reminded about re-inspection fee.

In Brief: NAD trims BPI claims, formula price-fixing in China, FDA warns Formulife and identifies spiked supplements, NBTY’s consumer redress

BPI discontinues claims at NAD’s behest; China levies fines for infant formula price-fixing; Public Citizen pans OTC Oxytrol; FDA advises ProNatural supplements cannot be topical; FDA warns Formulife on DMAA; FDA uncovers more spiked supplements; NBTY pays back consumers over omega-3 claims; Algean reminded about re-inspection fee.

Nasacort AQ Switch Rides On “Evolution Of Data” – Sanofi CMO

Charles Hugh-Jones, Sanofi’s chief medical officer for North America, says the firm will present clinical and consumer use data to allay concerns about the safety of intranasal corticosteroids, at the upcoming FDA advisory committee meeting to discuss the Rx-to-OTC switch of Nasacort AQ.

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