(a) Abbreviated applications are suitable for the following drug products within the limits set forth under § 314.93:
(1) Drug products that are the same as a listed drug. A “listed drug” is defined in § 314.3. For determining the suitability of an abbreviated new drug application, the term “same as” means identical in active ingredient(s), dosage form, strength, route of administration, and conditions of use, except that conditions of use for which approval cannot be granted because of exclusivity or an existing patent may be omitted. If a listed drug has been voluntarily withdrawn from or not offered for sale by its manufacturer, a person who wishes to submit an abbreviated new drug application for the drug shall comply with § 314.122.
(2) [Reserved]
(3) Drug products that have been declared suitable for an abbreviated new drug application submission by FDA through the petition procedures set forth under § 10.30 of this chapter and § 314.93.
(b) FDA will publish in the list listed drugs for which abbreviated applications may be submitted. The list is available from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, 202-783-3238.
[57 FR 17983, Apr. 28, 1992, as amended at 64 FR 401, Jan. 5, 1999]
Notes of Decisions
Dorsett v. Sandoz, Inc., 699 F. Supp. 2d 1142 (C.D. Cal. 2010).
· cites it 2× “See 21 C.F.R. § 314.92 (a)(1). “[T]he term ‘same as’ means identical in active ingredient(s), dosage form, strength, route of administration, and conditions of use.”
Fujisawa Pharm. Co., Ltd., & Fujisawa Usa, Inc. v. John K. Kapoor, 115 F.3d 1332 (7th Cir. 1997).
“§ 355®; 21 C.F.R. §§ 314.92 -.99. The abbreviation lies in the fact that, since the proprietary version had been approved upon a showing that it was safe and effective (the showing required for approval of an application for a new drug), the producer of the generic version need…”
Rodney Guilbeau v. Pfizer Inc., 880 F.3d 304 (7th Cir. 2018).
“5 As Depo-T itself demonstrates, having a registered trademark name and being designated as an RLD does not change a drug’s approval process classification at FDA.”
Eli Lilly & Co. v. Roussel Corp., 23 F. Supp. 2d 460 (D.N.J. 1998).
“21 C.F.R. § 314.92 (a). An applicant must file an Abbreviated Antibiotic Drug Application ("AADA”) which must demonstrate that the generic antibiotic will be bioequivalent to the innovator drug and will be manufactured and marketed in accordance with approved practices and…”
Mylan Pharm., Inc. v. Thompson, 139 F. Supp. 2d 1 (D.D.C. 2001).
“§§ 355 (j)(2)(A)(iii), (j)(4)(D)(i)-(ii); see also 21 C.F.R. § 314.92 (a)(1) (1999) (indicating the categories of drug products for which an ANDA may be filed).”
Mensing v. Wyeth, Inc., 562 F. Supp. 2d 1056 (D. Minnesota 2008).
“§ 3550 )(1); 21 C.F.R. § 314.92 (a). The manufacturer of a generic drug must show that the generic drug has the same active ingredients and is the “bioequivalent” of the listed drug.”
Takeda Pharm. USA, Inc. v. West-Ward Pharm. Corp., 72 F. Supp. 3d 539 (D. Del. 2014).
“3d at 1046 ; 21 C.F.R. § 314.92 (a)(1). . 35 U.S.C. § 271 (e)(2)(A) provides that "[i]t shall be an act of infringement to submit” an ANDA "for a drug claimed in a patent or the use of which is claimed in a patent.”
Serono Labs., Inc. v. Shalala, 974 F. Supp. 29 (D.D.C. 1997).
· cites it 2× “” 21 C.F.R. § 314.92 (a)(1). The Hatch-Waxman Amendments also require that an ANDA applicant demonstrate that a generic drug, is not unsafe “because of the type or quantity of inactive ingredients included .”
Pfizer Inc. v. Shalala, 1 F. Supp. 2d 38 (D.D.C. 1998).
· cites it 2× “§ 355 (j)(2)(A)(iii)), and despite the FDA’s own regulations interpreting this provision to require an “identical” dosage form ( 21 C.F.R. § 314.92 (a)(1)), the FDA in fact accepts ANDAs for review without first approving a suitability petition when the dosage form is not the…”
Bristol-Myers Squibb Co. v. Shalala, 892 F. Supp. 295 (D.D.C. 1995).
· cites it 4× “” 21 C.F.R. § 314.92 (a)(2). Under the abbreviated procedure, a generic manufacturer is not required to produce the results of clinical testing as long as the finished product satisfies the standards contained in the monograph for the pioneer version of the finished product.”
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