An Allegheny County judge has ruled that the "different manufacturers exception" to 21 U.S.C. Section 355(j)(2)(A)(v), which permits a generic drugmaker's warning label to deviate from the brand-name manufacturer's label in certain respects, does not allow generic manufacturers to include warnings that are not also disclosed on the brand-name equivalent's label.
Judge Rules Generic, Brand-Name Drugs Must List Same Warnings
The Legal Intelligencer
May 2, 2013
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