The FDA initially declared the tirzepatide shortage over in October, but the Outsourcing Facilities Association, a trade group for compounding pharmacists, sued, claiming the drug was still in ...
As expected by many, Eli Lilly And Co (NYSE:LLY) filed a motion to intervene as a defendant in a case between the Outsourcing Facilities Association and FarmaKeio Custom Compounding against the FDA.
For its part, the Outsourcing Facilities Association said in a report to the court that "Survey data from this month shows increasing numbers of patients unable to obtain branded GLP-1 agonist ...
Get Wall Street's Hottest Chart Every Morning As expected by many, Eli Lilly And Co LLY filed a motion to intervene as a defendant in a case between the Outsourcing Facilities Association and ...
The suit was filed by the Outsourcing Facilities Association (OFA), a trade group that represents 503B compounding pharmacies, seeking to overturn the FDA’s decision. After the suit was filed ...
The FDA declined to comment. The Outsourcing Facilities Association, which brought the lawsuit along with a Texas compounding pharmacy did not immediately respond to requests for comment.
In short, on October 2, 2024, FDA announced that Lilly had resolved the tirzepatide shortage, but five days later the Outsourcing Facilities Association (“OFA”) sued FDA on the grounds that ...
The Outsourcing Facilities Association (OFA) fundamentally disagrees with the FDA’s determination that the Tirzepatide injection product shortage is resolved. The fact of the matter is that ...
In a Citizen Petition posted on Regulations.gov, Novo Nordisk (NVO) noted that the Outsourcing Facilities Association, or OFA, has nominated liraglutide be added to their list of bulk drug ...
following a proposal by the trade group the Outsourcing Facilities Association (OFA) to add the molecule to its compounding roster. Apart from Victoza, which was approved for Type 2 diabetes in ...
The company highlights that existing FDA-approved formulations lack attributes that would necessitate compounding, while the Outsourcing Facilities Association’s (OFA) nomination relies on ...