C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER D—DRUGS FOR HUMAN USE › PART 314—APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG › Subpart C—Abbreviated Applications

21 C.F.R. § 314.97

Supplements and other changes to an approved ANDA

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(a) General requirements. The applicant must comply with the requirements of §§ 314.70 and 314.71 regarding the submission of supplemental ANDAs and other changes to an approved ANDA.

(b) Different listed drug. An applicant may not supplement an ANDA to seek approval of a drug referring to a listed drug that is different from the current reference listed drug identified in the ANDA. This paragraph (b) applies if changes are proposed in a supplement to the ANDA such that the proposed product is a pharmaceutical equivalent to a different listed drug than the reference listed drug identified in the ANDA. A change of reference listed drug must be submitted in a new ANDA. However, notwithstanding the limitation described in this paragraph (b), an applicant may supplement the ANDA to seek approval of a different strength.

[81 FR 69653, Oct. 6, 2016]
Notes of Decisions
Cited in 16 cases, 2008–2014 · leading case: Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009).
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Bartlett v. Mut. Pharm. Co., Inc., 659 F. Supp. 2d 279 (D.N.H. 2009). · cites it 4× “at 17987 (codified at 21 C.F.R. § 314.97 ). 5. Generic manufacturers’ reporting obligations The ANDA regulations promulgated after Hatch-Waxman require that “each applicant having an [ANDA] .”
Mensing v. Wyeth, Inc., 588 F.3d 603 (8th Cir. 2009). · cites it 2× “Yet, 21 C.F.R. § 314.97 compels generic manufacturers to “comply with the requirements of § []314.”
Demahy v. Wyeth Inc., 586 F. Supp. 2d 642 (E.D. La. 2008). · cites it 5× “Finally, this excerpt from § N of the 1989 Proposed Rule sheds light on the meaning of 21 C.F.R. § 314.97 (discussed in further detail below in section C(3)).”
Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010). · cites it 2× “On the other hand, what the FDA clearly did do to implement Hatch-Waxman cuts against Actavis’s position, or at the very least muddies congressional and agency intent: it promulgated 21 C.F.R. § 314.97 , entitled “Supplements and other changes to an approved abbreviated…”
Dorsett v. Sandoz, Inc., 699 F. Supp. 2d 1142 (C.D. Cal. 2010). · cites it 3× “70 (concerning supplements and other changes to an approved application); 21 C.F.R. § 314.97 (applying §§ 314.70 and 314.”
Yanise Germain v. Teva Pharm., USA, Inc, 756 F.3d 917 (6th Cir. 2014). “Under current regulations, brand-name and generic manufacturers have different labeling responsibilities, even though both are authorized to use the label supplement procedures.”
Gaeta v. Perrigo Pharm. Co., 630 F.3d 1225 (9th Cir. 2011). · cites it 2× “70 is expressly made applicable to ANDA holders by operation of 21 C.F.R. § 314.97 , which is located in Subpart C of the Regulations (entitled, “Abbreviated Applications”) and provides that ANDA applicants “shall comply with the requirements of §§ 314.”
Morris v. Wyeth, Inc., 642 F. Supp. 2d 677 (W.D. Ky. 2009). · cites it 2× “150 , and based on its understanding of 21 C.F.R. § 314.97 . The Demahy court reasoned that because the CBE regulation applies to ANDA holders, generic drug manufacturers have the ability to unilaterally change their labels to conform to heightened state warnings.”
Stacel v. Teva Pharm., USA, 620 F. Supp. 2d 899 (N.D. Ill. 2009). “But 21 C.F.R. § 314.97 is not silent — it states that generic drug manufacturers are obligated to comply with the same CBE provisions as brand-listed manufacturers are.”
VITATOE v. Mylan Pharm., Inc., 696 F. Supp. 2d 599 (N.D.W. Va. 2010). · cites it 2× “The circuit court’s analysis noted that the contention of the generic drug manufacturers, that they were prohibited from using the CBE process to modify or alter drug labels without FDA approval, was in direct conflict with 21 C.F.R. § 314.97 , which requires them to “ ‘comply…”
Fulgenzi v. Wyeth, Inc., 686 F. Supp. 2d 715 (N.D. Ohio 2010). “Because of this requirement, the generic drug manufacturers, like generic manufacturers in the present case, argued that they were prohibited from implementing a unilateral change without FDA approval.”
Kellogg v. Wyeth, 612 F. Supp. 2d 437 (D. Vt. 2009). “As this Court wrote in its earlier opinion, 21 C.F.R. § 314.97 requires an ANDA applicant to comply with the requirements of §§ 314.”
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