Document ID: FDA-2013-D-1675-0014
Agency: fda
Document Type: Notice
Title: New Chemical Entity Exclusivity Determinations for Certain Fixed-
Combination Drug Products; Guidance for Industry; Availability
Posted Date: 2014-10-16T04:00Z

[Federal Register Volume 79, Number 200 (Thursday, October 16, 2014)]
[Notices]
[Pages 62163-62164]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-24597]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1675]

New Chemical Entity Exclusivity Determinations for Certain Fixed-
Combination Drug Products; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``New Chemical Entity 
Exclusivity Determinations for Certain Fixed-Combination Drug 
Products.'' This guidance sets forth a change in the Agency's 
interpretation of the 5-year new chemical entity (NCE) exclusivity 
statutory and regulatory provisions as they apply to certain fixed-
combination drug products (fixed combinations). As described in the 
guidance, a drug product will be eligible for 5-year NCE exclusivity if 
it contains a drug substance that meets the definition of ``new 
chemical entity,'' regardless of whether that drug substance is 
approved in a single-ingredient drug product or in certain fixed-
combinations. This guidance finalizes the draft guidance issued in 
February 2014.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of this guidance 
to the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Bldg., 4th Floor, Silver Spring, MD 20993-0002. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nisha Shah, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002, 301-796-4455; or Jay 
Sitlani, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6272, Silver 
Spring, MD 20993-0002, 301-796-5202.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``New Chemical Entity Exclusivity Determinations for Certain 
Fixed-Combination Drug Products.'' This guidance sets forth a change in 
the Agency's interpretation of the 5-year NCE exclusivity provisions as 
they apply to certain fixed-combinations. Section 505(c)(3)(E)(ii) and 
(j)(5)(F)(ii) of the Food, Drug, and Cosmetic Act and 21 CFR 314.108, 
among other provisions, establish the scheme under which a drug product 
is eligible for 5-year NCE exclusivity. The Agency historically 
interpreted the term ``drug'' as it appears in the first sub-clause of 
the statutory provisions and in the definition of ``new chemical 
entity'' in its regulation to mean ``drug product.'' This resulted in a 
fixed-combination not being eligible for 5-year NCE exclusivity if it 
contained any drug substance that contained an active moiety that had 
been previously approved by the Agency, even if the fixed-combination 
also contained another drug substance that contained a previously 
unapproved active moiety.
    The Agency recognizes, however, that fixed-combinations have become 
increasingly prevalent in certain therapeutic areas and that these 
products play an important role in optimizing adherence to dosing 
regimens and improving patient outcomes. Therefore, to further 
incentivize the development of fixed-combinations containing previously 
unapproved active moieties, the guidance sets forth the Agency's 
revised interpretation regarding the eligibility for 5-year NCE 
exclusivity of certain fixed-combinations. Under the revised 
interpretation, the term ``drug'' in the relevant provisions is 
interpreted to mean ``drug substance'' or ``active ingredient,'' and 
not ``drug product.'' Accordingly, a drug product is eligible for 5-
year NCE exclusivity provided that it contains a drug substance that 
contains no active moiety that has been previously approved. This will 
permit a drug substance that meets the definition of new chemical 
entity (i.e., one that contains no previously approved active moiety) 
to be eligible for 5-year NCE exclusivity, regardless of whether it is 
approved in a single-ingredient drug product, in a fixed-combination 
with another drug substance that contains no other previously approved 
active moiety, or in a fixed-combination with another drug substance 
that contains a previously approved active moiety.
    In the Federal Register of February 24, 2014 (79 FR 10167), this 
guidance was published as a draft guidance. We have carefully reviewed 
and considered the comments that were received on the draft guidance. 
We have made editorial changes primarily for clarification.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on 5-year NCE exclusivity for certain fixed-
combinations. It does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. An alternative 
approach may be used if such approach satisfies the requirements of the 
applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

III. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information that are subject to review by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information in 21 CFR parts 314 have been 
approved under OMB control number 0910-0001.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

[[Page 62164]]

    Dated: October 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24597 Filed 10-15-14; 8:45 am]
BILLING CODE 4164-01-P