Document ID: FDA-2007-D-0369-0310
Agency: fda
Document Type: Notice
Title: Draft and Revised Draft Guidances for Industry Describing Product Specific Bioequivalence Recommendations Availability
Posted Date: 2014-12-30T05:00Z

[Federal Register Volume 79, Number 249 (Tuesday, December 30, 2014)]
[Notices]
[Pages 78447-78448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-30514]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]

Draft and Revised Draft Guidances for Industry Describing 
Product-Specific Bioequivalence Recommendations; 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 additional draft and revised draft product-specific 
bioequivalence (BE) recommendations. These recommendations provide 
product-specific guidance on the design of BE studies to support 
abbreviated new drug applications (ANDAs). In the Federal Register of 
June 11, 2010, FDA announced the availability of a guidance for 
industry entitled ``Bioequivalence Recommendations for Specific 
Products'', which explained the process that would be used to make 
product-specific BE recommendations available to the public on FDA's 
Web site. The BE recommendations identified in this notice were 
developed using the process described in that guidance.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comments on 
these draft and revised draft guidances before it begins work on the 
final versions of the guidances, submit either electronic or written 
comments on the draft and revised draft product-specific BE 
recommendations listed in this notice by March 2, 2015.

ADDRESSES: Submit written requests for single copies of the individual 
BE guidances to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 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section for electronic access to the draft guidance recommendations.
    Submit electronic comments on the draft product-specific BE 
recommendations 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: Kris Andre Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 4726, Silver Spring, MD 20993-0002, 240-402-7959.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA 
announced the availability of a guidance for industry entitled 
``Bioequivalence Recommendations for Specific Products,'' which 
explained the process that would be used to make product-specific BE 
recommendations available to the public on FDA's Web site at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
    As described in that guidance, FDA adopted this process to develop 
and disseminate product-specific BE recommendations and to provide a 
meaningful opportunity for the public to consider and comment on those 
recommendations. Under that process, draft recommendations are posted 
on FDA's Web site and announced periodically in the Federal Register. 
The public is encouraged to submit comments on those recommendations 
within 60 days of their announcement in the Federal Register. FDA 
considers any comments received, and either publishes final 
recommendations or publishes revised draft recommendations for comment. 
Recommendations were last announced in the Federal Register on April 2, 
2014 (79 FR 18561). This notice announces draft product-specific 
recommendations, either new or revised, that are posted on FDA's Web 
site.

II. Drug Products for Which New Draft Product-Specific BE 
Recommendations Are Available

    FDA is announcing the availability of a new draft guidance for 
industry on product-specific BE recommendations for drug products 
containing the following active ingredients:

Table 1--New Draft Product-Specific BE Recommendations for Drug Products
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A...............................  Acetaminophen; Aspirin; Caffeine.
                                  Acetaminophen; Butalbital; Caffeine;
                                   Codeine phosphate.
                                  Acyclovir.
                                  Aripiprazole.
B...............................  Benzyl alcohol.
                                  Betamethasone valerate.
                                  Bosutinib monohydrate.
                                  Brimonidine tartrate; Brinzolamide.
                                  Buprenorphine hydrochloride; Naloxone
                                   hydrochloride.
C...............................  Cobicistat; Elvitegravir;
                                   Emtricitabine; Tenofovir disoproxil
                                   fumarate.
                                  Conjugated estrogens.
D...............................  Dapsone.
                                  Darunavir ethanolate.
I...............................  Ibuprofen sodium.
L...............................  Levothyroxine sodium (multiple
                                   reference listed drugs).
                                  Lidocaine; Prilocaine.
                                  Lomitapide mesylate.
                                  Lurasidone hydrochloride.
M...............................  Metoprolol tartrate.
N...............................  Nepafenac (multiple reference listed
                                   drugs).
P...............................  Posaconazole.
R...............................  Raltegravir potassium.
                                  Regorafenib.
S...............................  Selegine hydrochloride.
T...............................  Testosterone.
                                  Tofacitinib citrate.
                                  Treprostinil.
V...............................  Vandetanib.
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III. Drug Products for Which Revised Draft Product-Specific BE 
Recommendations Are Available

    FDA is announcing the availability of a revised draft guidance for 
industry on product-specific BE recommendations for drug products 
containing the following active ingredients:

   Table 2--Revised Draft Product-Specific BE Recommendations for Drug
                                Products
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A...............................  Adapalene (multiple reference listed
                                   drugs and dosage forms).
                                  Adapalene; Benzoyl peroxide.
B...............................  Brimonidine tartrate (multiple
                                   reference listed drugs).
                                  Brinzolamide.
D...............................  Doxorubicin hydrochloride.
E...............................  Ethinyl estradiol; Levonorgestrel.
H...............................  Hydrocodone bitartrate; Ibuprofen.
K...............................  Ketoconazole.
M...............................  Memantine hydrochloride (multiple
                                   dosage forms).
                                  Methylprednisolone acetate.
N...............................  Nebivolol hydrochloride.
                                  Nisoldipine.
P...............................  Phenytoin sodium (multiple reference
                                   listed drugs).
S...............................  Sevelamer carbonate.

[[Page 78448]]

 
                                  Sevelamer hydrochloride.
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    For a complete history of previously published Federal Register 
notices related to product-specific BE recommendations, please go to 
http://www.regulations.gov and enter Docket No. FDA-2007-D-0369.
    These draft and revised draft guidances are being issued consistent 
with FDA's good guidance practices regulation (21 CFR 10.115). These 
guidances represent the Agency's current thinking on product-specific 
design of BE studies to support ANDAs. They do not create or confer any 
rights for or on any person and do 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.

IV. Comments

    Interested persons may submit either electronic comments on any of 
the specific BE recommendations posted on FDA's Web site 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. The guidances, notices, and 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.

V. 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.

    Dated: December 23, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-30514 Filed 12-29-14; 8:45 am]
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