MYLAN CYSTAGON (CYSTEAMINE) NDA APPROVED FOR NEPHROPATHIC CYSTINOSIS on Aug. 12, just two weeks after becoming "approvable" ("The Pink Sheet" Aug. 8, In Brief). The generic drug manufacturer will produce cysteamine bitartrate capsules for the approximately 200 children in the U.S. who suffer from the disease, which results in progressive kidney failure, weak bones and stunted growth because of an accumulation of the amino acid cystine in patients' kidney tubules.
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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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