Aug. 25 Federal Register notice announces a Sept. 9 joint meeting of FDA's OTC Drugs and Gastrointestinal Drugs Advisory Committees to review SmithKline's NDA requesting marketing approval of an OTC version of the prescription antiulcer drug Tagamet (cimetidine) for episodic heartburn relief ("The Tan Sheet" May 31, p. 1). SmithKline's original NDA also included an indication for nocturnal heartburn relief but the company has elected to pursue one indication for the time being following discussions with FDA. Meeting begins 8:30 a.m. in conference rooms D and E of FDA's Parklawn Building. . . .
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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 European Medicines Agency’s human medicines committee, the CHMP, has recommended 14 new medicines for pan-EU approval this month, including five orphan medicines.
The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.
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