In H. Lundbeck A/S, et al. v. Lupin Ltd., et al., Nos. 2022-1194, 2022-1208, and 2022-1246 (December 7, 2023), the Federal Circuit held that generic pharmaceutical companies may continue to use skinny labels to avoid...more
The Biden administration recently determined that it has the right to seize patents covering certain high-priced medicines, in an apparent effort to take a more aggressive approach to lowering drug prices. See Targeting...more
After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does...more
10/17/2016
/ Failure To Warn ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Labeling ,
Pharmaceutical Industry ,
PLIVA v Mensing ,
Preemption ,
Product Defects ,
Proposed Amendments ,
Proposed Regulation ,
Warning Labels