HYPERCHOLESTEROLEMIA DRUGS "SHOULD NOT BE SOLD OTC," FDA states in an "guidance for industry" on the "OTC treatment of hypercholesterolemia," released Oct. 2. Issued as a follow-up to the May advisory committee meeting on Bristol-Myers Squibb's Rx-to-OTC switch application for Questran powder for reconstruction, the guidance states that the Center for Drug Evaluation & Research concurs with the advisory committee recommendation that hypercholesterolemia treatment requires both preliminary and ongoing medical management. CDER "therefore believes that drugs for the treatment of hypercholesterolemia should not be sold OTC in the United States."
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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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