There May Be A Paradigm Shift In Generic Drug Labeling

Law360, New York (November 12, 2013, 12:42 PM EST) -- On Wednesday, Nov. 13, the U.S. Food and Drug Administration will publish a proposed rule in the Federal Register that will mandate that generic drug firms update their labels for drugs under approved abbreviated new drug applications to add warnings, precautions, adverse reactions, contraindications and certain other information even if the corresponding branded company has not implemented the same labeling change.

At present, the FDA’s regulations do not allow an ANDA holder to update its labeling to add new safety information until the brand company that...
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