288 F.3d 141 (4th Cir. 2002), the words “for such disease or condition” suggest Congress intended to make section 360cc “disease-specific, not drug-specific,” and the rest of the statutory language focuses on protecting approved indications, not intended off-label uses. See id. at 145 (reasoning that the statutory language is “directed at FDA approved-use, not generic competitor intended-use”). The statute creates limits on the approval of an “application,” which by implication directs FDA to evaluate what is written on the application. 21 U.S.C. § 360cc. An application will necessarily include only stated indications, not intended off-label uses. Id. § 355(b). Second, FDA’s interpretation conforms to the statutory purposes of the Orphan Drug Act. See Abbott Labs., 920 F.2d at 988 (<HOLDING>). Spectrum raises a number of policy arguments,
recognizing statutory credit recognizing the circuit split and noting that this sharp division means that the statute is readily susceptible to different interpretations recognizing a presumption of reasonableness recognizing that this court applies an appellate presumption of reasonableness to a withinguidelines sentence recognizing that an interpretations conformity to statutory purposes affects its reasonableness