ROTOP - DMSA
Generic name: kit for the preparation of technetium tc99m succimer injection
Dosage form: injection, powder, lyophilized, for solution
THERAGNOSTICS
Theragnostics Inc.
150 Grossman Drive, Suite 306
Braintree, MA 02184
IMPORTANT ORDERING INFORMATION
December 1, 2020
Subject: New Ordering Procedures for ROTOP DMSA Kit for the Preparation of Technetium Tc99m Succimer Injection
Dear Healthcare Professional,
Please note the following information prior to placing an order for ROTOP DMSA Kit for the Preparation of Technetium Tc99m Succimer Injection. On September 1, 2020, GE Healthcare sold their radiopharmacy chain to a third party, Radioisotope Life Sciences (RLS), and no longer have the capability to make radiolabelled 99mTc-DMSA.
To place an order for ROTOP DMSA Kit for the Preparation of Technetium Tc99m Succimer Injection (Theragnostics), please contact your local nuclear pharmacy, ex. Cardinal Health, Jubilant, RLS, UPPI, Pharmalogic or another independent nuclear pharmacy. You can also contact Medi-Physics Inc., dba GE Healthcare, 1-800-292-8514, 8:00 AM to 6:30 PM Eastern time; or via web portal address ci.gehealthcare.com/us.
CONTACT NUMBERS: Please use the following contact numbers as appropriate:
Phone: 1-617-286-7479
Fax: 1-617-398-6337
Sincerely,
Gregory Mullen
President & CEO
THERAGNOSTICS
Theragnostics Inc.
150 Grossman Drive, Suite 306
Braintree, MA 02184
IMPORTANT PRESCRIBING INFORMATION
December 1, 2020
Subject: Temporary importation of Kit for the Preparation of Technetium Tc99m Succimer Injection to address drug shortage issues
Dear Healthcare Professional,
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.
At this time, no other entity except ROTOP Pharmaka GmbH, Germany through its US Agent, Theragnostics, and Theragnostics' distributor, Medi-Physics Inc., dba GE Healthcare, is authorized by the FDA to import or distribute the DMSA Kit for the Preparation of Technetium Tc99m Succimer Injection in the U.S. FDA has not approved ROTOP Pharmaka GmbH's Kit for DMSA Preparation of Technetium Tc99m Succimer Injection product in the U.S.
Effective immediately, and during this temporary period, Theragnostics will offer the following presentation of ROTOP DMSA Kit for the Preparation of Technetium Tc99m Succimer Injection:
| Product | Strength | Size | Marketing Authorization # |
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MEDICAL DEPARTMENTS
Cardiology
Pediatrics
Diabetes Care
Pre-natal Care
Ultrasound Echocardiogram
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