SANDOZ LESCOL (FLUVASTATIN) IS FIRST "ENTIRELY SYNTHETIC" HMG- CoA reductase inhibitor and "is in part structurally distinct from the fungal derivatives of this therapeutic class," labeling states. Lescol was approved as a cholesterol-lowering agent on Dec. 31 ("The Pink Sheet" Jan. 3, p. 18). It will be the fourth HMG-CoA reductase inhibitor on the market, after Merck's Mevacor (lovastatin) and Zocor (simvastatin) and Bristol-Myers Squibb's Pravachol (pravastatin).
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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.’
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The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.
FDA staff are trying to plan for program implementation in the absence of critical eligibility and other details, although guidance may be coming soon.
