Ezplaz Freeze-Dried Plasma is expected to benefit those in remote areas who need plasma products, as well as military personnel.
The U.S. Food and Drug Administration (FDA) announced that it has granted a biologics license to Vascular Solutions, LLC for Ezplaz Freeze Dried Plasma (FDP). This marks the first freeze-dried plasma product licensed for use in the U.S. It is intended for use in adult patients in need of plasma who are not able to access other plasma products.
“Patients experiencing life-threatening bleeding in combat zones, disasters, rural settings, or other austere environments may now have faster access to plasma when conventional frozen plasma is unavailable,” said Acting Director Karim Mikhail of the Center for Biologics Evaluation and Research (CBER). “This milestone action addresses an important unmet medical need — particularly for our military personnel and others who may be far from traditional hospital infrastructure.”
Ezplaz can be stored at room temperature, remains stable after being exposed to temperature fluctuations, and is able to be rapidly reconstituted. It is also packaged in a plastic bag, rather than a glass bottle, which helps to reduce the risk of breakage during transport.
As the Lord Leads, Pray with Us…
- For Acting Commissioner Diamantas as he heads the FDA and its evaluations of new treatments and therapies.
- For Acting Director Mikhail as he promotes the freeze-dried plasma for transfusion patients.
- For Secretary Kennedy and HHS officials as they review innovative new drugs and treatments for patients in the U.S.
Sources: Food and Drug Administration
