And FDA has long interpreted the labeling provision to authorize additional variances in cases where there are “differences [with respect to] expiration date, formulation, bioavailability, or pharmacokinetics, labeling revisions made to comply with current FDA labeling guidelines or other guidance, or omission of an indication or other aspect of labeling protected by patent or accorded exclusivity under section 505(j)(4)(D) of the act.” 21 C.F.R. § 314.94(a)(8)(iv). Congress has never overridden FDA’s interpretation of the statutory exceptions nor limited FDA’s authority to supplement the statute.

For an ANDA applicant to rely on FDA's previous determination of safety and effectiveness, its application must, among other things, include information to show that the generic drug (i) has the same active ingredient, conditions of use, dosage form, strength, and route of administration as the RLD, and (ii) is bioequivalent to, and has the same labeling as, the RLD. See 21 U.S.C. § 355(j)(2)(A); 21 C.F.R. § 314.94(a). Meeting the approval criteria means that the generic drug can be expected to provide the same level of safety and effectiveness as – and as a general matter can be substituted for – the innovator product.

(D.I. 95 at 20.) Sandoz specifically argues that FDA’s August 18, 2004 decision amends 21 C.F.R. § 314.94(a)(12)(iii) because the “language of the indication actually approved is broader than [procedural sedation in the intensive care setting]—it covers procedural use both in and out of the ICU.” (Id.)

FDA regulations are the same. See 21 C.F.R. § 314.94(a)(7)(i) (ANDA applicant must show bioequivalence to "the reference listed drug"); see also Bristol-Myers, 923 F. Supp. at 216 ("An applicant for an abbreviated approval of a generic drug must provide information to show that the new drug is the bioequivalent to the listed drug.") (emphasis added, quotations and citation omitted).

If any one of these disciplines concludes that the application is not approvable, the application will not be approved. See generally 21 U.S.C. § 355; 21 C.F.R. §§ 314.94, 314.105, 10 See, e.g., American Therapeutics, 755 F. Supp. at 2 (noting that the circumstance of FDA’s withdrawal under section 355(e) is “often caused by receipt of new information”) (emphasis added).

(PLIVA, Inc. v. Mensing, supra, 564 U.S. 604, 613, 131 S. Ct. 2567, 180 L. Ed. 2d 580 [requiring sameness both pre- and post- marketing approval].) The requirement that a Case 2:16-cv-08055-TJH-JEM Document 46-1 Filed 04/24/17 Page 10 of 28 Page ID #:345 11 MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF DEFENDANT CITRON PHARMA, LLC’S NOTICE OF MOTION AND MOTION TO DISMISS PLAINTIFFS’ ORIGINAL COMPLAINT PURSUANT TO FRCP RULES 12(b)(6), 9(b), AND 8(a) 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 28 generic drug be the “same as” the reference listed drug (“RLD”) (21 U.S.C. § 355(j)(2)(A); 21 C.F.R. § 314.94(a)(3)) is due to the fact that the generic drug’s approval is based on the safety and efficacy information for the RLD.

94 make it abundantly clear that a generic version of a drug must be materially the same as the already approved brand n me drug. 21 C.F.R. § 314.94(a)(1)-(9); see 21 U.S.C. § 355. Moreover, GSK’s reliance on United States v. Generix Drug Corp., 460 U.S. 453, 460 (1983) for the proposition that generic and branded rugs are “different” products is misplaced.

A. Each Of Plaintiffs’ Causes Of Action Is Preempted By Federal Law. As discussed above, the FDCA and Hatch-Waxman Amendments operate to govern the approval of both brand-name and generic drugs. See 21 C.F.R. § 314.50(c)(2)(i) (brand-name); 21 C.F.R. § 314.94(a)(8) (generic). This regulatory scheme preempts all actions rooted in failure-to-warn claims under the Supremacy Clause of the U.S. Constitution.

Pursuant to the Federal Food, Drug and Cosmetic Act (“FDCA”), the FDA regulates the approval of both brand name and generic drugs. See 21 C.F.R. § 314.50(c)(2)(i) (brand name); 21 C.F.R. §314.94(a)(8) (generic). The amniodarone manufactured by Sandoz is a generic; therefore the court will focus here on the regulatory scheme applicable to generic drugs.

FDC Act§ 505G)(4)(G), 21 U.S.C. § 355(j)(4)(G); 21 C.F.R. § 314.127(a)(4). FDC Act§ 505(j)(2)(A)(v); 2 I U.S.C. § 355(jX2)(A)(v). 21 C.F.R. § 314.94(a)(8)(iv).