FDA Approves INDIUM DTPA IN 111 (NDA 017707) for Intrathecal Diagnostic Use

The U.S. Food and Drug Administration (FDA) has granted approval for INDIUM DTPA IN 111 under application number NDA017707. The product is marketed under the brand name INDIUM DTPA IN 111 and contains the active ingredient INDIUM IN-111 PENTETATE DISODIUM (indium‑111 pentetate) at a strength of 1 mCi/mL. INDIUM DTPA IN 111 is classified as a radioactive diagnostic agent and a radiopharmaceutical activity. It is intended for intrathecal administration and is listed as a human prescription drug. The product’s National Drug Code (NDC) is 17156-251-08. The manufacturer listed is Medi‑Physics, Inc. dba GE Healthcare. The FDA submission history includes multiple supplemental and manufacturing (CMC) submissions dating from 1982 through 2016, with the most recent labeling supplement submitted on 27 September 2004 (submission number 10). All submissions have a status of “AP” (approved).