(Reuters) - The U.S. Food and Drug Administration on Tuesday defended its proposal to require generic drugmakers to update the prescribing information on their products if they become aware of new ...

Supreme Court set to consider cert. petition on generic drug use of “skinny labels” to avoid infringing method of use patents. Court expected to consider cert. petition during court conference on May ...

The federal government re-ignited a controversial proposal to give generic drug makers the power to unilaterally update product labels to reflect new safety information, a proposal that drew criticism ...

Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced ...

Amarin has shored up additional data to back its Vascepa pill to protect against heart problems in patients who’ve already had a heart attack. But piling up more prevention evidence might not help ...

After a ‘skinny label’ was used to market a generic version of a pricey brand-name medicine, more consumers gained access to the lower-cost copycat drug and saved on out-of-pockets cost, a new study ...