FDA REVIEW OF MINOXIDIL SAFETY DATA FOR HAIR GROWTH INDICATION may be completed in October, FDA Cardio-Renal Drugs Div. Deputy Director Stewart Ehrreich told "The Pink Sheet." Ehrreich, who is the reviewer for the safety section of the minoxidil NDA, is leaving the agency Oct. 24 to join Biometric Research Institute. He said he will not leave FDA until he completes his portion of review of the NDA. Upjohn filed an NDA for minoxidil as an anti-baldness drug in December 1985. The firm had given the drug the tradename Regaine, but recently changed the name to Rogaine at the urging of FDA. Upojohn said FDA felt the name Regaine might imply uniform effectiveness and sounded more appropriate for an OTC drug. Ehrreich said minoxidil reviewers believe the drug should go before FDA's Dermatologic Drugs Advisory Cmte. because of the wide population exposure potential if the drug is approved. Ehrreich said that perhaps only oral contraceptives would exceed minoxidil in terms of population exposure. The cmte. is not scheduled to meet again this year. Ehrreich is joining Biometric Research Institute after nine years at FDA. Prior to 1980, when he became deputy director of the Cardio-Renal Div., he served as group leader of anti-hypertensives in the division. Before joining FDA, Ehrreich also spent 12 years in industry, as a scientist at SmithKline & French, Ciba-Geigy and Schering-Plough. FDA has not named a successor to fill the deputy director slot. At BRI, an Arlington, Virginia-based firm that provides regulatory and research services to industry, Ehrreich will be joining former FDA Cardiovascular Device Div. Director Glenn Rahmoeller as a senior technical adviser. Rahmoeller left the agency last August. Ehrreich will be consulting with pharmaceutical companies on their NDAs, specifically preclinical and clinical data and the logistics of moving applications through FDA. BRI designs and conducts clinical studies of medical devices, diagnostics, pharmaceuticals and biologics for both domestic and foreign manufacturers.
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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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