U.S. Food and Drug Administration recently issued the following announcement.
Technetium Tc99m Succimer Injection (DMSA)
Status: Currently in Shortage
»Date first posted: 10/15/2014
»Therapeutic Categories: Medical Imaging
GE Healthcare (Revised 06/06/2017)
Company Contact Information: 800-292-8514
Presentation: DMSA Kit for the Preparation of Technetium Tc99m Succimer Injection (NDC 17156-525-01)
Availability and Estimated Shortage Duration: Efforts are being made to return the DMSA product back to the marketplace. Estimated return date at this time is 1st quarter 2020.
Shortage Reason (per FDASIA): Manufacturing delays
Theragnostics Inc. (Reverified 06/29/2018)
Company Contact Information: 617-286-7479
Presentation: ROTOP DMSA (Kit for the Preparation of Technetium Tc99m Succimer Injection). One vial contains 1.74 mg powder with the active substance: 1.0 mg succimer. Five vials included in a carton (NDC 71647-001-01)
Availability and Estimated Shortage Duration: Available
Related Information:
Due to the current critical shortage of DMSA Kit for the Preparation of Technetium Tc99m Succimer, Theragnostics Inc. (Theragnostics) is coordinating with the U.S. Food and Drug Administration (FDA) to increase the availability of the drug. Theragnostics has initiated temporary importation of DMSA Kit for the Preparation of Technetium Tc99m Succimer Injection into the U.S. market. This product is marketed in Germany and is manufactured in Dresden, Germany by ROTOP Pharmaka GmbH for Theragnostics.
Dear Healthcare Professional Letter
Shortage Reason (per FDASIA): Other
