Allegan, Mich.-based Perrigo's development partner, Teva Pharmaceutical Industries, along with Novartis subsidiary Sandoz separately received final FDA approval for Abbreviated New Drug Applications for private-label versions of McNeil Consumer Healthcare's Zyrtec-D extended-release tablets, according to FDA. The OTC cetirizine 5 mg/pseudoephedrine 120 mg extended-release tablets carry an indication for 12-hour relief of indoor and outdoor allergy symptoms and nasal congestion, Perrigo says in a March 6 release. FDA approved Zyrtec and Zyrtec-D for OTC use in November, and Perrigo wasted no time in launching its Zyrtec equivalent in January, ahead of the branded product (1"The Tan Sheet" Nov. 19, 2007, In Brief and 2"The Tan Sheet" Feb. 11, 2008, p. 9). The firm says it anticipates shipping the product in the next 90 days...
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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.’
US FDA Commissioner Martin Makary will establish "national priorities" used to select sponsors for the pilot of “tumor board-style” drug reviews that would start before Phase III is completed.
Despite following the path of the popular Project Orbis, the cell and gene therapy international collaborative review pilot is being reconsidered by the FDA's new management.
Too many “uninformative” drug trials fail to justify the excessively high prices of many medicines, while there is too much evidentiary uncertainty in European pricing and reimbursement systems, warned Anja Schiel from Norway’s NOMA.
