Perrigo files an abbreviated new drug application for a generic equivalent of the heart burn reliever Zegerid OTC, drawing a patent infringement suit from Schering-Plough HealthCare Products filed Sept. 20 in the U.S. District Court of New Jersey. Perrigo notes a federal court in Delaware ruled earlier this year in a similar suit that the same patents were invalid due to obviousness (1"The Tan Sheet" April 19, 2010). An appeal is pending in the Delaware case, which is related to Zegerid prescription products. Perrigo said in a Sept. 24 release that it notified Schering-Plough prior to filing the ANDA for the omeprazole 20 mg /sodium bicarbonate 1,100 mg drug. The private labeler cites data from Chicago-based IRI Symphony that places sales of Zegerid OTC at about $60 million annualized in the most recent month
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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.’
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.
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.
