An 1advertisement in the Oct. 23 issue of All You magazine says Novartis' Prevacid 24HR could be "available as early as November 12th." The Web site for the proton pump inhibitor, 2www.prevacid24hr.com, has been updated with additional information about the product, including packaging and drug facts. Novartis, which licenses Prevacid 24HR (lansoprazole 15 mg) from Takeda Pharmaceuticals, appears to position the drug as an alternative to prescription heartburn remedies, rather than attempting to draw away users of Procter & Gamble's Prilosec OTC (omeprazole 20 mg) - as the company said upon FDA approval of the switch in May (3"The Tan Sheet" May 18, 2009). The OTC PPI market may grow more crowded after December, when FDA's decision on Santarus/Schering-Plough's Zegerid (omeprazole 20 mg/sodium bicarbonate) is due (4"The Tan Sheet" June 29, 2009, In Brief)
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
Pink Sheet reporter and editors discuss CBER Director Vinay Prasad’s expectation to stay out of routine application decisions, despite the agency’s top-down leadership approach, and the extent of proposed FDA budget cuts.
The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”
The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.
