Woodruff, Wisc.-based Hillestad Pharmaceuticals is violating a 2000 consent decree by making unapproved drug claims for its dietary supplement products, FDA says in Oct. 1 "Talk Paper." The agency told the firm in a letter it may face a contempt proceeding if it does not cease claims made in promotional materials identified during a recent inspection. FDA "also directs the firm to pay liquidated damages in the amount of $23,000, which reflects sales of Opti-Cran, Hi-C Level, ginkgo biloba and St. John's wort that were made in violation of the court order." The consent decree was part of a settlement of an FDA/Department of Justice case against Hillestad for marketing unapproved new drugs...
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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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