June 02, 2014
By Kurt R. Karst –
FDA’s recent announcement that the Agency seized more than $11,185,000 worth of unapproved drugs marketed by Ascend Laboratories (“Ascend”) is the latest, and most clear example yet of FDA taking action pursuant to the Agency’s September 19, 2011 Marketed Unapproved Drugs Compliance Policy Guide, Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs (“Unapproved Drugs CPG”) (Docket No. FDA-2011-D-0633), which is the cornerstone of FDA’s Unapproved Drugs Initiative. FDA’s Unapproved Drugs CPG is specifically called out in the Verified Complaint for Forfeiture In Rem filed in the U.S. District Court for the Southern District of Ohio last month.
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FDA’s recent announcement that the Agency seized more than $11,185,000 worth of unapproved drugs marketed by Ascend Laboratories (“Ascend”) is the latest, and most clear example yet of FDA taking action pursuant to the Agency’s September 19, 2011 Marketed Unapproved Drugs Compliance Policy Guide, Sec. 440.100, Marketed New Drugs Without Approved NDAs or ANDAs (“Unapproved Drugs CPG”) (Docket No. FDA-2011-D-0633), which is the cornerstone of FDA’s Unapproved Drugs Initiative. FDA’s Unapproved Drugs CPG is specifically called out in the Verified Complaint for Forfeiture In Rem filed in the U.S. District Court for the Southern District of Ohio last month.
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