[Federal Register Volume 79, Number 141 (Wednesday, July 23, 2014)]
[Notices]
[Pages 42800-42801]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-17293]


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

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.

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

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, 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 September 22, 2014.

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access to the draft guidance recommendations.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: Kris Andr[eacute], Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, rm. 1615, 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 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 
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
------------------------------------------------------------------------
 
------------------------------------------------------------------------
A............................  Alogliptin benzoate.
                               Alogliptin benzoate; Metformin
                                hydrochloride (HCl).
                               Alogliptin benzoate; Pioglitazone HCl.
                               Amoxicillin (multiple reference listed
                                drugs).
                               Atenolol; Chlorthalidone.
C............................  Canagliflozin.
                               Carbidopa.
                               Carbinoxamine maleate.

[[Page 42801]]

 
                               Cefixime.
                               Colestipol HCl.
                               Crizotinib.
D............................  Daunorubicin citrate.
                               Diflorasone diacetate.
                               Dimethyl fumarate.
                               Diphenhydramine HCl.
                               Doxycycline (multiple reference listed
                                drugs).
                               Doxylamine succinate; Pyridoxine HCl.
E............................  Esomeprazole strontium.
                               Ethinyl estradiol; Levonorgestrel and
                                Ethinyl estradiol.
                               Ethinyl estradiol; Norethindrone acetate.
F............................  Fosfomycin tromethamine.
G............................  Gentamicin sulfate.
H............................  Hydromorphone HCl.
L............................  Lanreotide acetate.
                               Linagliptin; Metformin HCl.
                               Lomustine.
M............................  Menthol; Methyl salicylate.
                               Metformin HCl; Sitagliptin phosphate.
O............................  Ospemifene.
                               Oxcarbazepine.
P............................  Paroxetine mesylate.
                               Promethazine (multiple reference listed
                                drugs and strengths).
                               Propranolol HCl.
R............................  Ropinirole HCl.
S............................  Sucralfate (multiple reference listed
                                drugs and dosage forms).
T............................  Tacrolimus.
Z............................  Zolmitriptan.
------------------------------------------------------------------------

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
------------------------------------------------------------------------
 
------------------------------------------------------------------------
D............................  Dronedarone HCl.
                               Duloxetine HCl.
E............................  Ergocalciferol
                               Esomeprazole magnesium.
F............................  Fluorouracil.
H............................  Hydrochlorothiazide; Moexipril HCl.
I............................  Imatinib mesylate.
L............................  Lansoprazole.
M............................  Mesalamine (multiple reference listed
                                drugs).
N............................  Nevirapine.
                               Nilotinib HCl monohydrate.
P............................  Pentosan polysulfate sodium.
------------------------------------------------------------------------

    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: July 17, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-17293 Filed 7-22-14; 8:45 am]
BILLING CODE 4164-01-P