is consistent with how the agency has interpreted “intended use” outside of the ANDA approval context to mean “the objective intent of the persons legally responsible for the labeling of drugs.” 21 C.F.R. § 201.128. Under that regulation, intent “is determined by such persons’ expressions” or “may be shown by the circumstanc ows FDA to permit Sandoz to promote misbranded drugs. But the ANDA approval stage is not the point in time at which FDA must evaluate a generic’s purpose beyond that which is set forth in the ANDA itself. If Sandoz improperly deviates from that stated purpose by marketing its drug for the Colorectal Indication, FDA can pursue a later enforcement action to ensure the generic is labeled accurately. See Wash. Legal Found. v. Henney, 202 F.3d 331, 333 (D.C. Cir. 2000) (<HOLDING>). Because FDA’s interpretation of the Orphan
holding that brand name manufacturers cannot be held liable for injuries caused by products they did not manufacture under arkansas law recognizing products liability and products actions based on negligence as part of the general maritime law recognizing that substantial change is a defense to a products liability claim recognizing that a manufacturers direct advertising or explicit promotion of a products offlabel uses is likely to provoke an fda misbranding or intended use enforcement action holding that industrial wastes were not products under a products hazard exception because they were not intended for consumption sale or use by others 