Food and Drug Administration (FDA) for orforglipron by the end of the year
It might be what's growing where it shouldn't be
Key Takeaway: The distinction between research-grade and pharmaceutical-grade peptides represents a critical safety consideration
These programs include medications such as Ozempic, Rybelsus, and Victoza (for managing blood glucose levels in type 2 diabetes), which are available at no cost or at a very low cost to eligible individuals
On the same date, Julian Gill also requested case numbers for all adverse events in the FAERS system related to tirzepatide and semaglutide products produced by Empower Pharmacy in Houston, Texas (both the 503A and 503B products). Noa Metta submitted on September 24 a request for FDA Form 483 inspection reports, warning letters, Establishment Inspection Reports, and adverse event reports relating to pharmacies conducting unauthorized compounding practices, involving semaglutide, tirzepatide, or similar drugs, between January 1, 2022, and the present. Several additional requests addressed non-compounding issues related to GLP-1 drugs, two mentioning Eli Lilly and one mentioning Ozempic and Wegovy
