FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Technetium Tc99m Succimer Injection (DMSA)
Status: Currently in Shortage
»Date first posted: 10/15/2014
»Therapeutic Categories: Medical Imaging

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GE Healthcare (Revised 06/06/2017)

Company Contact Information:
800-292-8514

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
DMSA Kit for the Preparation of Technetium Tc99m Succimer Injection (NDC 17156-525-01) Efforts are being made to return the DMSA product back to the marketplace. Estimated return date at this time is 1st quarter 2020. Manufacturing delays

Theragnostics Inc. (Revised 09/07/2017)

Company Contact Information:
617-286-7479

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
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) Projected availability date is September 1, 2017 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.

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