JD Supra

Ineffective Skinny Label Leaves Generic Liable Despite Effort to Carve-Out the Patented Indication

Before Moore, Newman, Prost (dissent). Panel rehearing of an appeal from the U.S. District Court for the District of Delaware Summary: Substantial evidence supported the jury verdict of induced ...
MM&M

FDA wants clearer indications, usage language on product labels

The FDA has offered more suggestions on product labelling with its latest draft guidance focused on a label’s indications and usage section, recommending drug companies make their language as clear as ...
FiercePharma

FDA Begins Process To Remove Breast Cancer Indication From Avastin Label

Drug not shown to be safe and effective in breast cancer patients SILVER SPRING, Md., Dec. 16, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration announced today that the agency is ...
Nasdaq

CHMP Backs NVO's Ozempic EU Label Update for Cardiovascular Indication

Novo Nordisk NVO announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that Ozempic’s (once-weekly ...