Prilosec 1 Use For GERD Endorsed In 16-2 Joint Committee Vote
• By The Tan Sheet
Possible long-term use of omeprazole to prevent chronic heartburn or gastroesophageal reflux disease (GERD) is acceptable, despite an OTC indication for only 14-day use, FDA advisory committee members determined at a meeting in Bethesda, Md. June 21
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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The first 100 days of the Trump Administration were notable for an extraordinary decline in the number of public meetings hosted by the US Food and Drug Administration. But the schedule changed quickly.
Joint procurement, if used by member states to respond to potential pricing and access challenges caused by a US most favored nations pricing policy, would cause more uncertainty for pharmaceutical companies, warn industry representatives.