On December 19, 2024, FDA formally announced the end of the tirzepatide shortage in a Declaratory Order issued to Eli Lilly & Co. (“Lilly”). Lilly is tirzepatide’s patentholder and the manufacturer of the two branded versions...more
1/27/2025
/ Compliance ,
Drug Compounding ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Intellectual Property Litigation ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Supply Shortages ,
Trade Secrets
I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more
1/15/2025
/ Biologics ,
Chevron Deference ,
Chevron v NRDC ,
Drug Compounding ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Regulatory Requirements ,
SCOTUS ,
Summary Judgment ,
Supply Shortages
On December 17, 2024, the FDA published five (5) warning letters previously issued to makers of knockoff GLP-1 drugs. Four of the five warning letters were to companies (specifically, Xcel Research, Prime Vitality, Summit...more
12/20/2024
/ Distributors ,
Drug Compounding ,
False Advertising ,
FDA Approval ,
FDA Warning Letters ,
Knockoffs ,
Labeling ,
Manufacturers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Violations