[Code of Federal Regulations]
[Title 21, Volume 5]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR314.54]

[Page 112-113]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--Continued
 
PART 314--APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG--Table of Contents
 
                         Subpart B--Applications
 
Sec. 314.54  Procedure for submission of an application requiring investigations for approval of a new indication for, or other change from, a listed drug.

    (a) The act does not permit approval of an abbreviated new drug 
application for a new indication, nor does it permit approval of other 
changes in a listed drug if investigations, other than bioavailability 
or bioequivalence studies, are essential to the approval of the change. 
Any person seeking approval of a drug product that represents a 
modification of a listed drug (e.g., a new indication or new dosage 
form) and for which investigations, other than bioavailability or 
bioequivalence studies, are essential to the approval of the changes 
may, except as provided in paragraph (b) of this section, submit a 
505(b)(2) application. This application need contain only that 
information needed to support the modification(s) of the listed drug.
    (1) The applicant shall submit a complete archival copy of the 
application that contains the following:
    (i) The information required under Sec. 314.50(a), (b), (c), (d)(1), 
(d)(3), (e), and (g), except that Sec. 314.50(d)(1)(ii)(c) shall contain 
the proposed or actual master production record, including a description 
of the equipment, to be used for the manufacture of a commercial lot of 
the drug product.
    (ii) The information required under Sec. 314.50 (d)(2), (d)(4) (if 
an anti-infective drug), (d)(5), (d)(6), and (f) as needed to support 
the safety and effectiveness of the drug product.
    (iii) Identification of the listed drug for which FDA has made a 
finding of safety and effectiveness and on which finding the applicant 
relies in seeking approval of its proposed drug product by established 
name, if any, proprietary name, dosage form, strength, route of 
administration, name of listed drug's application holder, and listed 
drug's approved application number.
    (iv) If the applicant is seeking approval only for a new indication 
and not for the indications approved for the listed drug on which the 
applicant relies, a certification so stating.
    (v) Any patent information required under section 505(b)(1) of the 
act with respect to any patent which claims the drug for which approval 
is sought or a method of using such drug and to which a claim of patent 
infringement could reasonably be asserted if a person not licensed by 
the owner of the patent engaged in the manufacture, use, or sale of the 
drug product.
    (vi) Any patent certification or statement required under section 
505(b)(2) of the act with respect to any relevant patents that claim the 
listed drug or that claim any other drugs on which investigations relied 
on by the applicant for approval of the application were conducted, or 
that claim a use for the listed or other drug.
    (vii) If the applicant believes the change for which it is seeking 
approval is entitled to a period of exclusivity, the information 
required under Sec. 314.50(j).
    (2) The applicant shall submit a review copy that contains the 
technical sections described in Sec. 314.50(d)(1), except that 
Sec. 314.50(d)(1)(ii)(c) shall contain the proposed or actual master 
production record, including a description of the equipment, to be used 
for the manufacture of a commercial lot of the drug product, and 
paragraph (d)(3), and the technical sections described in paragraphs 
(d)(2), (d)(4), (d)(5), (d)(6),

[[Page 113]]

and (f) when needed to support the modification. Each of the technical 
sections in the review copy is required to be separately bound with a 
copy of the information required under Sec. 314.50 (a), (b), and (c) and 
a copy of the proposed labeling.
    (3) The information required by Sec. 314.50 (d)(2), (d)(4) (if an 
anti-infective drug), (d)(5), (d)(6), and (f) for the listed drug on 
which the applicant relies shall be satisfied by reference to the listed 
drug under paragraph (a)(1)(iii) of this section.
    (4) The applicant shall submit a field copy of the application that 
contains the technical section described in Sec. 314.50(d)(1), a copy of 
the information required under Sec. 314.50(a) and (c), and certification 
that the field copy is a true copy of the technical section described in 
Sec. 314.50(d)(1) contained in the archival and review copies of the 
application.
    (b) An application may not be submitted under this section for a 
drug product whose only difference from the reference listed drug is 
that:
    (1) The extent to which its active ingredient(s) is absorbed or 
otherwise made available to the site of action is less than that of the 
reference listed drug; or
    (2) The rate at which its active ingredient(s) is absorbed or 
otherwise made available to the site of action is unintentionally less 
than that of the reference listed drug.

[57 FR 17982, Apr. 28, 1992; 57 FR 61612, Dec. 28, 1992, as amended at 
58 FR 47351, Sept. 8, 1993; 59 FR 50364, Oct. 3, 1994]