FDA Licenses First Freeze-Dried Plasma Product
Ezplaz can be stored at room temperature and reconstituted in about a minute, giving providers a backup when conventional plasma is unavailable.
- On Wednesday, the Food and Drug Administration approved Ezplaz Freeze Dried Plasma, the first freeze-dried plasma product in the United States. The agency granted a biologics license to Vascular Solutions, a subsidiary of Teleflex, for adult patients requiring transfusions when conventional products are unavailable.
- Packaged in plastic to prevent breakage, Ezplaz is designed for disaster response, rural care, and combat settings. It is available in Group AB and Group A low-titer blood types, enabling immediate use before a patient's blood type is known.
- The approval arrives as the American Red Cross grapples with a national blood supply crisis, with donations at a four-year summer low. Dr. Pampee Young, the organization's chief medical officer, told Reuters the product is "unlikely by itself to materially alleviate the blood-component shortages hospitals experience most frequently."
- Separately, the FDA approved a new over-the-counter Tylenol formulation combining acetaminophen and naproxen sodium. Manufacturer Kenvue stated the tablet works within 30 minutes and offers pain relief for up to 12 hours.
- This approval comes despite President Donald Trump and Health and Human Services Secretary Robert F. Kennedy Jr. claiming Tylenol poses pregnancy risks. Medical groups dispute these claims, citing lack of backing from the full body of scientific evidence.
11 Articles
11 Articles
FDA Licenses First Freeze-Dried Plasma Product
(MedPage Today) -- The FDA licensed Ezplaz, the first freeze-dried plasma product available to adults in need of transfusion, on Wednesday. Ezplaz is intended for patients who need plasma -- such as those who are bleeding, need massive transfusion...
The Independent
The Independent (US)FDA approves new version of Tylenol with added ingredient
New fast-acting non-opioid drug will soon be available
The Food and Drug Administration (Fda) of the United States has granted marketing authorisation for Ezplaz Freeze Dried Plasma (Fdp), the first approved lyophilised plasma product in the United States. Ezplaz is intended for transfusion in adult patients in need of plasma and for whom other plasma products are not available. Ezplaz patients who are facing life-threatening bleeding in war zones, disaster contexts, rural areas or difficult environ…
Coverage Details
Bias Distribution
- 50% of the sources are Center
Factuality
To view factuality data please Upgrade to Premium
