Judges Tosses Claims Against Generics Manufacturers Over Heartburn Drug

July 15, 2021

A federal court judge has dismissed all complaints against generic drug manufacturers and pharmacy chains regarding allegations that they knowingly sold the heartburn drug ranitidine containing a likely carcinogen.

In her decision, Judge Robin Rosenberg in U.S. District Court for the Southern District of Florida cited a discrepancy between state and federal law regarding prescription drug labeling, noting that many states require drugmakers to revise their labels to reflect new warnings, but FDA regulations mandate that generic labels reflect the labeling of the brand-name reference drug.

As state law is pre-empted by federal law, generics makers could not update their labeling or redesign their ranitidine products because the FDA had not approved those changes, the judge said.

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