The impact of FDA’s proposed rule on generic drugs labeling

Darshan Bhatt
PharmaBiz
December, 2013

The FDA recently released a proposal for the rule entitled “Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products”. Under the new proposed rule, by using the same process as brand drug manufacturers to update safety information in the product labeling, generic drug manufacturers would be able to update product labeling with new safety information in the same way. However, the proposed change in the generic label is required to be finally approved by the FDA so that the brand label is also changed, and both brand and generic drug products ultimately have the same prescribing information.

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