Perrigo receives FDA approval for ANDA 75-077 Feb. 25 and will launch the product by July 31; the generic is equivalent to McNeil Consumer Healthcare's Tylenol Arthritis Extended Relief Caplets. Perrigo had expected approval for the 650 mg acetaminophen pain reliever/fever reducer before the end of 1999 (1"The Tan Sheet" Nov. 22, In Brief). The Allegan, Mich.-based private labeler's introduction of store brand extended release acetaminophen will likely disrupt sales of Tylenol Arthritis, which held a 2.5% dollar share of the internal analgesic tablet market in 1999 with sales of $66.8 mil., according to Information Resources, Inc. of Chicago
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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.’
Clarity on what transferable exclusivity vouchers may look like for new antimicrobial drugs could be nearing. Denmark’s new presidency of the Council of the EU has prioritized concluding its negotiations with European Parliament over the legislative overhaul of the EU’s pharmaceutical legislation.
After pursuing Alchem International for breaches of EU antitrust rules – relating to a cartel over the SNBB pharmaceutical ingredient used in Buscopan and its generics – the European Commission has now hit the firm with a €489,000 fine.
Bayesian statistics could help clinical trial sponsors to include external information in their analyses, but concerns around bias and incorrect conclusions remain, the European Medicines Agency said.
