Jubilant DraxImage receives FDA approval for 12-Hour shelf-life for DRAXIMAGE® MAA
Jubilant DraxImage receives FDA approval for 12-Hour shelf-life for DRAXIMAGE® MAA
Montreal, QC, October 26, 2017 – Jubilant DraxImage Inc. (“DraxImage”), a wholly-owned subsidiary of Jubilant Pharma, is pleased to announce the U.S. Food and Drug Administration (FDA) approval for the extension of the in-use shelf life of DRAXIMAGE® MAA (Kit for the Preparation of Technetium Tc 99m Albumin Aggregated Injection) to 12 hours post-reconstitution.
DRAXIMAGE MAA is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. It may also be used in adults as an imaging agent to aid in the evaluation of peritoneovenous (LeVeen) shunt patency.
The new approved label allows for the use of DRAXIMAGE MAA for up to 12 hours following reconstitution, a significant change from the previous 6 hour limit. This extension will add flexibility in how the product is used, creating efficiencies for imaging departments and radiopharmacies across the United States.
DraxImage and Jubilant Pharma Senior Vice-President of Medical & Regulatory Affairs and Chief Medical Officer, Dr. Norman LaFrance stated, “Jubilant DraxImage is very proud of this latest approval by the FDA. With this shelf-life extension to 12 hours, DRAXIMAGE MAA will enhance the way radiopharmacies serve hospitals. They can now deliver more timely products to patients needing critical diagnostic tests such as ventilation-perfusion scans.”
“This approval reinforces DraxImage’s commitment to growing, expanding and investing in the field of nuclear medicine. Our continued mission is to bring value to our products enabling physicians to deliver high quality diagnostic studies for the patients in need,” commented Mike Rossi, Jubilant DraxImage President.
DRAXIMAGE MAA is available to all US customers, today. For further information please contact DraxImage Customer Service at: 1-888-633-5343 or customerservice@draximage.com
Indications and Usage: Technetium Tc 99m Albumin Aggregated Injection is a lung imaging agent which may be used as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients.Technetium Tc 99m Albumin Aggregated Injection may be used in adults as an imaging agent to aid in the evaluation of peritoneovenous (LeVeen) shunt patency.
Important Safety Information: DRAXIMAGE MAA should not be administered to patients with severe pulmonary hypertension or persons with a history of hypersensitivity reactions to products containing human serum albumin.
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