Warner-Lambert receives FDA approval March 8 for an efficacy supplement to NDA 20-745 for the labeled indication "For the prevention of heartburn, acid indigestion and sour stomach brought on by consuming food and beverages." The effervescent tablet (ranitidine 75 mg) was cleared Feb. 26, 1998 for heartburn treatment ("The Tan Sheet" March 2, 1998, p. 1). The launch of the product is still pending. Warner-Lambert may have been awaiting approval of the prevention indication before introducing the line extension to Zantac 75
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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 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.”
Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.