[Federal Register Volume 77, Number 115 (Thursday, June 14, 2012)]
[Notices]
[Pages 35688-35689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-14477]


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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. 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 (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. 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 13, 2012.

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, 10903 New 
Hampshire Ave., Bldg. 51, rm. 2201, 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access to the draft guidance recommendations.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: K. Geoffrey Wu, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-9326.

SUPPLEMENTARY INFORMATION:

I. Background

    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 at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As 
described in that guidance, FDA

[[Page 35689]]

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 of March 28, 2012 (77 FR 
18827). This notice announces draft product-specific recommendations, 
either new or revised, that are being posted on FDA's Web site 
concurrently with publication of this notice.

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

    FDA is announcing new draft product-specific BE recommendations for 
drug products containing the following active ingredients:

A
    Aliskiren hemifumarate; amlodipine besylate
    Alvimopan
    Azilsartan medoxomil
B
    Bacitracin
    Boceprevir
C
    Cefpodoxime proxetil (multiple reference listed drugs (RLDs))
    Cefprozil (multiple RLDs)
    Cetirizine HCl
    Ciprofloxacin HCl; hydrocortisone
    Clomiphene citrate
D
    Dabigatran etexilate mesylate
    Dexamethasone; tobramycin
    Dinoprostone
    Diphenhydramine; ibuprofen
E
    Erythromycin
F
    Famotidine; ibuprofen
G
    Gabapentin enacarbil
I
    Itraconazole
K
    Ketoconazole
L
    Lacosamide
M
    Malathion
    Morphine sulfate; naltrexone HCl
P
    Podofilox
R
    Rotigotine
    Rufinamide
T
    Tapentadol HCl
    Tetrabenazine
Z
    Zolpidem tartrate

III. Drug Products for Which Revised Draft Product-Specific BE 
Recommendations Are Available

    FDA is announcing revised draft product-specific BE recommendations 
for drug products containing the following active ingredients:

D
    Dexamethasone; tobramycin (multiple RLDs)
E
    Everolimus
L
    Loteprednol etabonate
    Loteprednol etabonate; tobramycin
S
    Sorafenib tosylate
    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 number 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 to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments on any of the 
specific BE recommendations posted on FDA's Web site. 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.

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 8, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-14477 Filed 6-13-12; 8:45 am]
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