80 FR 37273 - Product-Specific Bioequivalence Recommendations; Draft and Revised Draft Guidances for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 125 (June 30, 2015)

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-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.

[Federal Register Volume 80, Number 125 (Tuesday, June 30, 2015)]
[Notices]
[Pages 37273-37275]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-16013]


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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.

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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-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 August 31, 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 
March 9, 2015 (80 FR 12502). This notice announces draft product-
specific

[[Page 37274]]

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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Abacavir sulfate; Dolutegravir sodium; Lamivudine.
Afatinib dimaleate.
Alendronate sodium.
Aspirin.
Azelastine hydrochloride; Fluticasone propionate.
Budesonide; Formoterol fumarate dihydrate.
Calcium carbonate; Famotidine; Magnesium hydroxide.
Canagliflozin; Metformin hydrochloride.
Cyclophosphamide.
Cyproheptadine hydrochloride.
Dabrafenib mesylate.
Dapagliflozin propanediol.
Dexbrompheniramine maleate and Pseudoephedrine sulfate.
Dolutegravir sodium.
Donepezil hydrochloride; Memantine hydrochloride.
Doxycycline hyclate.
Droxidopa.
Eliglustat tartrate.
Empagliflozin.
Emtricitabine; Tenofovir disoproxil fumarate.
Enzalutamide.
Fentanyl.
Indomethacin.
Lanthanum carbonate.
Levalbuterol tartrate.
Levomilnacipran hydrochloride.
Macitentan.
Methazolamide.
Miglitol.
Naloxegol oxalate.
Naproxen sodium.
Nitroglycerin.
Omeprazole; Sodium bicarbonate.
Oxybutynin (multiple reference listed drugs and dosage forms).
Oxycodone hydrochloride.
Primaquine phosphate.
Sildenafil citrate.
Simeprevir sodium.
Sofosbuvir.
Tolcapone.
Vemurafenib.
Vismodegib.
Vortioxetine hydrobromide.
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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 Cholestyramine
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Doxycycline hyclate.
Prasugrel hydrochloride.
Tiagabine hydrochloride.
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    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

[[Page 37275]]

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: June 24, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-16013 Filed 6-29-15; 8:45 am]
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