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In 2006, the FDA amended its final rule to add phenylephrine bitartrate (an effervescent formulation) to phenylephrine hydrochloride as GRASE over-the-counter nasal decongestant products included in that final monograph. Another meta-analysis was conducted by industry in 2007, which came to the opposite conclusion.
Below, I do a wicked deep dive into the data and highlight crucial implications about spending, profits, pharmacies, plans, patients, program integrity, and more. And don't forget to put on your ruby slippers and hear from Doctor of Thinkology Adam J. There are important limitations to these data. All rights reserved.
That issue, in turn, involves product identification (another problem in MDLs) and a pointer for pharmacies that want to avoid being involved in pharmaceutical litigation. That manufacturer had relinquished all of its rights to Zantac in December 2006 – eight years before plaintiff began using it in 2014.
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