FDA grants final approval for McNeil Consumer Healthcare's generic Zyrtec to nine firms, the agency announces Dec. 27. Actavis, Apotex, Caraco Pharmaceutical Laboratories, Mylan Pharmaceuticals, Par Pharmaceutical Companies, Perrigo, Ranbaxy Laboratories, Sandoz and Wockhardt will offer the cetirizine HCl allergy and hives treatment in 5 mg and 10 mg tablets. FDA approved prescription-strength Zyrtec for over-the-counter sale Nov. 16, one week after approving McNeil's switch application for its Zyrtec-D allergy treatment decongestant combination product (1"The Tan Sheet" Nov. 12, 2007, p. 9). OTC Zyrtec is expected to be available for retail sale in late January...
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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.
