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 D—FDA Action on Applications and Abbreviated Applications

21 C.F.R. § 314.105

Approval of an NDA and an ANDA

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(a) FDA will approve an NDA and send the applicant an approval letter if none of the reasons in § 314.125 for refusing to approve the NDA applies. FDA will issue a tentative approval letter if an NDA otherwise meets the requirements for approval under the Federal Food, Drug, and Cosmetic Act, but cannot be approved because there is a 7-year period of orphan exclusivity for the listed drug under section 527 of the Federal Food, Drug, and Cosmetic Act and § 316.31 of this chapter, or if a 505(b)(2) application otherwise meets the requirements for approval under the Federal Food, Drug, and Cosmetic Act, but cannot be approved until the conditions in § 314.107(b)(3) are met; because there is a period of exclusivity for the listed drug under § 314.108; because there is a period of pediatric exclusivity for the listed drug under section 505A of the Federal Food, Drug, and Cosmetic Act; or because there is a period of exclusivity for the listed drug under section 505E of the Federal Food, Drug, and Cosmetic Act. A drug product that is granted tentative approval is not an approved drug and will not be approved until FDA issues an approval after any necessary additional review of the NDA. FDA's tentative approval of a drug product is based on information available to FDA at the time of the tentative approval letter (i.e., information in the 505(b)(2) application and the status of current good manufacturing practices of the facilities used in the manufacturing and testing of the drug product) and is therefore subject to change on the basis of new information that may come to FDA's attention. A new drug product may not be marketed until the date of approval.

(b) FDA will approve an NDA and issue the applicant an approval letter on the basis of draft labeling if the only deficiencies in the NDA concern editorial or similar minor deficiencies in the draft labeling. Such approval will be conditioned upon the applicant incorporating the specified labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed labeling prior to marketing.

(c) FDA will approve an NDA after it determines that the drug meets the statutory standards for safety and effectiveness, manufacturing and controls, and labeling, and an ANDA after it determines that the drug meets the statutory standards for manufacturing and controls, labeling, and, where applicable, bioequivalence. While the statutory standards apply to all drugs, the many kinds of drugs that are subject to the statutory standards and the wide range of uses for those drugs demand flexibility in applying the standards. Thus FDA is required to exercise its scientific judgment to determine the kind and quantity of data and information an applicant is required to provide for a particular drug to meet the statutory standards. FDA makes its views on drug products and classes of drugs available through guidance documents, recommendations, and other statements of policy.

(d) FDA will approve an ANDA and send the applicant an approval letter if none of the reasons in § 314.127 for refusing to approve the ANDA applies. FDA will issue a tentative approval letter if an ANDA otherwise meets the requirements for approval under the Federal Food, Drug, and Cosmetic Act, but cannot be approved because there is a 7-year period of orphan exclusivity for the listed drug under section 527 of the Federal Food, Drug, and Cosmetic Act and § 316.31 of this chapter, or cannot be approved until the conditions in § 314.107(b)(3) or (c) are met; because there is a period of exclusivity for the listed drug under § 314.108; because there is a period of pediatric exclusivity for the listed drug under section 505A of the Federal Food, Drug, and Cosmetic Act; or because there is a period of exclusivity for the listed drug under section 505E of the Federal Food, Drug, and Cosmetic Act. A drug product that is granted tentative approval is not an approved drug and will not be approved until FDA issues an approval after any necessary additional review of the ANDA. FDA's tentative approval of a drug product is based on information available to FDA at the time of the tentative approval letter (i.e., information in the ANDA and the status of current good manufacturing practices of the facilities used in the manufacturing and testing of the drug product) and is therefore subject to change on the basis of new information that may come to FDA's attention. A new drug product may not be marketed until the date of approval.

[81 FR 69654, Oct. 6, 2016]
Notes of Decisions
Cited in 89 cases (17 in the last 5 years), 1987–2026 · leading case: Wyeth v. Levine, 555 U.S. 555 (2009).
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Wyeth v. Levine, 555 U.S. 555 (2009). · cites it 2× “There is, however, an FDA regulation that permits a manufacturer to make certain changes to its label before receiving the agency's approval. Among other things, this "changes being effected" (CBE) regulation provides that if a manufacturer is changing a label to "add or…”
Mylan Labs., Inc. v. Tommy G. Thompson, Sec'y, United States Dep't of Health & Human Servs., 389 F.3d 1272 (D.C. Cir. 2005). · cites it 4× “(citing 21 C.F.R. § 314.105 (a)). 4 Accordingly, the FDA informed Mylan: “Final Approval cannot be granted earlier than the date of a court decision finding the patents invalid, not infringed or unenforceable, or the expiration date of the patent and any period of pediatric…”
Barr Labs., Inc. v. Thompson, 238 F. Supp. 2d 236 (D.D.C. 2002). · cites it 6× “” 21 C.F.R. § 314.105 (a) (1985). The text of the provision remained unchanged in 1987.”
State Ex Rel. Wilson v. Ortho-McNeil-Janssen Pharm., Inc., 777 S.E.2d 176 (S.C. 2015). · cites it 4× “§ 355 (2006); 21 C.F.R. § 314.105 (b) (2008)). Subsequent to approval of the new drug application, a drug manufacturer must submit a supplemental application to the FDA in order to effect any changes in the drug label.”
Mead Johnson Pharm. Grp., Mead Johnson & Co. v. Otis R. Bowen, Sec'y of H.H.S., 838 F.2d 1332 (D.C. Cir. 1988). · cites it 4× “More generally, the FDA stated that, in accordance with 21 C.F.R. § 314.105 , 4 its policy had always been that “the date of the approval letter is the date of approval of the application.”
United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). · cites it 2× “§ 355 ; 21 C.F.R. § 314.105 (b) (2008). Generally speaking, a manufacturer may only change a drug label after the FDA approves a supplemental application.”
Colacicco v. Apotex Inc., 521 F.3d 253 (3rd Cir. 2008). · cites it 2× “" 21 C.F.R. § 314.105 (b). However, "[s]uch approval will be conditioned upon the applicant incorporating the specified labeling changes exactly as directed, and upon the applicant submitting to FDA a copy of the final printed labeling prior to marketing.”
Teva Pharm. USA, Inc. v. Sebelius, 595 F.3d 1303 (D.C. Cir. 2010). · cites it 2× “If we refrained from adjudicating this dispute now, Teva would almost certainly face competition from Apotex on April 6, see 21 C.F.R. § 314.105 (d) (explaining that a "tentative" approval is the same as a final approval with a delayed effective date)—an injury that would not be…”
Ethypharm S.A. France v. Abbott Labs., 707 F.3d 223 (3rd Cir. 2013). “See 21 C.F.R. § 314.105 (a) (explaining that once notice of an approved application is received by letter, marketing of the drug may begin, unless the FDA or some other provision of law has delayed that effective date).”
Demahy v. Actavis, Inc., 593 F.3d 428 (5th Cir. 2010). · cites it 2× “to show wheth *432 er or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof” or "results of such tests [that] show [the] drug is unsafe for use under such conditions.”
Knipe v. SmithKline Beecham, 583 F. Supp. 2d 553 (E.D. Pa. 2008). · cites it 2× “” 21 C.F.R. § 314.105 (a). The FDA “will approve an application and issue the applicant an approval letter .”
Levine v. Wyeth, 2006 VT 107 (Vt. 2008). · cites it 2× “57, and quoting 21 C.F.R. § 314.105 (b)). Once a drug and its label have been approved, any changes to the label ordinarily require submission and FDA approval of a "Supplemental NDA.”
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— 21 C.F.R. § 314.105(b) — 1 case
Eisai Inc. v. United States Food & Drug Admin., 134 F. Supp. 3d 384 (D.D.C. 2015).
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