
[Federal Register Volume 80, Number 182 (Monday, September 21, 2015)]
[Notices]
[Pages 57000-57002]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-23571]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Product-Specific Bioequivalence Recommendations; Draft and 
Revised Draft Guidances for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of additional draft and revised draft product-specific 
bioequivalence (BE) recommendations. The recommendations provide 
product-

[[Page 57001]]

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'' that 
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 November 20, 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 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electronic access to the draft guidance recommendations.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: Xiaoqiu Tang, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.

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'' that 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 as a means 
to develop and disseminate product-specific BE recommendations and 
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 
June 30, 2015 (80 FR 37273). 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
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Aclidinium bromide
Acyclovir
Aminocaproic acid
Apremilast
Benazepril hydrochloride; Hydrochlorothiazide
Brimonidine tartrate
Carbidopa; Levodopa
Ceritinib
Clobetasol propionate
Clomipramine hydrochloride
Clonidine hydrochloride
Cobicistat
Cysteamine bitartrate
Dapagliflozin propanediol; Metformin hydrochloride
Dasabuvir sodium; Ombitasvir; Paritaprevir; Ritonavir
Desvenlafaxine fumarate
Eslicarbazepine acetate
Esomeprazole magnesium
Ferric citrate
Fluticasone propionate (multiple reference listed drugs)
Formoterol fumarate
Idelalisib
Ledipasvir; Sofosbuvir
Levocarnitine
Loperamide hydrochloride; Simethicone
Mometasone furoate monohydrate
Naltrexone HCL; Bupropion HCL
Netupitant; Palonosetron hydrochloride
Nintedanib esylate
Nortriptyline hydrochloride
Pirfenidone
Pomalidomide
Ponatinib hydrochloride
Rivaroxaban
Ruxolitinib phosphate
Suvorexant
Tasimelteon
Tedizolid phosphate
Tramadol hydrochloride
Trimipramine maleate
------------------------------------------------------------------------

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
------------------------------------------------------------------------
 
-------------------------------------------------------------------------
Acitretin
Amantadine hydrochloride
Benzonatate
Carbamazepine
Colesevelam hydrochloride
Cyclophosphamide
Dabigatran etexilate mesylate
Dasatinib
Desvenlafaxine succinate
Esomeprazole magnesium
Estradiol
Ethinyl estradiol; Norethindrone
Gabapentin
Isotretinoin
Minocycline hydrochloride
Naltrexone
Sevelamer carbonate
Sirolimus
------------------------------------------------------------------------

    For a complete history of previously published Federal Register 
notices related to product-specific BE recommendations, 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 establish any rights 
for anyone and are not binding on FDA or the public. You may use an 
alternative approach if it 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.

[[Page 57002]]

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: September 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-23571 Filed 9-18-15; 8:45 am]
 BILLING CODE 4164-01-P


