Compared to other diluents like sterile water, saline, or dextrose water, bacteriostatic water can offer better stability for certain medications
At this temperature, most reconstituted peptides maintain stability for 6-12 months
In its lawsuit, the OFA said that the FDAs decision to end the shortage was a reckless and arbitrary move and could deprive patients of a vital treatment for type 2 diabetes and obesity. In an interview with BioSpace last month, David Rosen, partner at Foley & Lardner, said that the lawsuit is a precedent in this area. Prior to the OFA suit, no one has ever challenged the FDAs decision to remove a therapy from the drug shortage list. The OFA case is still ongoing, with the next court update due on Thursday
Tracking forces accountability, and the difference in body composition between people who prioritize protein and those who do not is dramatic
Analysts said the positive vote signaled regulatory support for the companys plans to offer the products