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Persberichten / 24th maart 2020
Curium Announces Approval of PulmotechTM MAA (kit for the preparation of technetium Tc 99m albumin aggregated injection) by the U.S. Food and Drug Administration
Download as PDF: English
(St. Louis, MO – March 24, 2020) – Curium announced today that the U.S. Food and Drug Administration (FDA) has approved Pulmotech MAA. When labeled to technetium Tc 99m, Pulmotech MAA is a single-photon emission agent for lung imaging as an adjunct in the evaluation of pulmonary perfusion and, in adults, to aid in the evaluation of peritoneovenous shunt patency. Curium has marketed a similar version of MAA (macroaggregated albumin) in Europe for more than a decade and expects to begin selling product to U.S. customers in April 2020.
“We are excited to bring Pulmotech MAA to the market,” said Dan Brague, Curium CEO, North America. “Our customers have been asking us to expand our product portfolio to include an MAA product for several years. I am happy to share that we have listened and we are now able to help supply the needs of clinicians and their patients. This is the first in a series of anticipated approvals over the next two years in which Curium will bring solutions to the market.”
“I am excited to bring a second MAA product to the U.S. market and look forward to engaging with customers on Pulmotech MAA immediately. This brand offers our customers significant value and is a tremendous addition to our growing portfolio of products in the U.S.” said Andy Farrow, VP of Sales, North America.
About Pulmotech MAA
Curium offers customers the flexibility to purchase vials in either a pack of 5 or in a box of 30. To order any product in Curium’s portfolio, please contact Customer Service at 1-888-744-1414.
Technetium Tc 99m Albumin Aggregated Injection is a radioactive diagnostic agent indicated for:
- Lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients.
- Scintigraphy of peritoneovenous shunt as an aid in the evaluation of its patency in adults.
IMPORTANT RISK INFORMATION
- Patients with severe pulmonary hypertension.
- Persons with a history of hypersensitivity reactions to products containing human serum albumin.
Warnings and Precautions
- Serious adverse reactions have been reported in patients with pulmonary hypertension.
- Serious hypersensitivity reactions have been reported.
- Deaths after administration to patients with severe pulmonary hypertension and serious hypersensitivity reactions have been reported.
Use In Specific Populations
- Lactation: Temporarily discontinue breastfeeding and discard breast milk for 13 hours after administration.
Please see Full Prescribing Information at https://www.curiumpharma.com/pulmotech-maa.
Curium is a world-class nuclear medicine solutions provider with more than a century of industry experience. Curium is the largest vertically integrated radiopharmaceutical product manufacturer in the industry.
With manufacturing facilities across Europe and the United States, Curium supports over 14 million patients around the world with SPECT, PET, and therapeutic radiopharmaceuticals. The Curium brand name is inspired by the work of radiation researchers Marie and Pierre Curie and emphasizes a focus on nuclear medicine. To learn more, visit curiumpharma.com. For more information about this press release, please contact Janet Ryan media contact for Curium: firstname.lastname@example.org.