Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability, 10535-10536 [2012-4037]

Download as PDF Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of final product-specific bioequivalence (BE) recommendations. The recommendations provide productspecific 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, ‘‘Bioequivalence Recommendations for Specific Products,’’ which explained the process that would be used to make productspecific 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: Submit written or electronic comments on Agency guidances at any time. 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 selfaddressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the recommendations. Submit electronic comments to https://www.regulations.gov. Submit written comments on product-specific BE recommendations to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Doan T. Nguyen, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240– 276–8608. SUPPLEMENTARY INFORMATION: srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: I. Background In the Federal Register of June 11, 2010, FDA announced the availability of VerDate Mar<15>2010 16:37 Feb 21, 2012 Jkt 226001 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 https://www.fda.gov/CDER/ GUIDANCE/bioequivalence/ 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, 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. Once finalized, the recommendations are posted on FDA’s Web site and announced in the Federal Register. This notice announces final product-specific recommendations that were posted on FDA’s Web site in October 2011. For a complete history of previous Federal Register notices relating to product-specific BE recommendations, please go to https://www.regulations.gov and enter docket number FDA–2007–D– 0369. These guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The 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. II. Drug Products for Which Final Product-Specific BE Recommendations are Available FDA is announcing final productspecific BE recommendations for drug products containing the following active ingredients: A Acetaminophen; Caffeine; Dihydrocodeine Bitartrate C Cephalexin Ciprofloxacin D Desmopressin Acetate PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 10535 E Eletriptan HBr F Fenoprofen Calcium Fludrocortisone Acetate G Glimepiride; Pioglitazone H Hydroxyzine Pamoate (multiple RLDs) I Imatinib Mesylate L Lansoprazole Levetiracetam Linezolid M Meprobamate Methotrexate Sodium (multiple RLDs) Methylprednisolone Acetate Metoclopramide HCl N Nadolol Nifedipine Nilutamide Nisoldipine Nitazoxanide Nitrofurantoin Nitrofurantoin Macrocrystalline O Oxybutynin Chloride P Phendimetrazine Tartrate (multiple RLDs) Phentermine HCl (multiple RLDs) Phytonadione Pregabalin Propafenone HCl Pyridostigmine Bromide R Raltegravir Potassium Ramelteon S Scopolamine Selegiline Sorafenib Tosylate T Tamoxifen Citrate Telbivudine Temazepam Terbinafine HCl Toremifene Citrate V Voriconazole Z Zolpidem III. 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. 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 E:\FR\FM\22FEN1.SGM 22FEN1 10536 Federal Register / Vol. 77, No. 35 / Wednesday, February 22, 2012 / Notices guidance, notices, and received comments are available for public examination in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA through FDMS only at https://www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either https://www.fda.gov/CDER/GUIDANCE/ bioequivalence/default.htm or https:// www.regulations.gov. Dated: February 14, 2012. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2012–4037 Filed 2–21–12; 8:45 am] BILLING CODE 4160–01–P 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. The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft product-specific bioequivalence (BE) recommendations. The recommendations provide productspecific 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 document 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 srobinson on DSK4SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 16:37 Feb 21, 2012 Jkt 226001 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 April 23, 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 selfaddressed 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 https://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: Doan T. Nguyen, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240– 276–8608. SUPPLEMENTARY INFORMATION: in the Federal Register of January 25, 2012 (77 FR 3777). This notice announces draft product-specific recommendations, either new or revised, that have been posted on the FDA’s Web site in the period from July 1, 2011, through November 30, 2011. For a complete history of previously published Federal Register notices relating to product-specific BE recommendations, please go to https:// 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). The 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. 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 https://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm. As described in that guidance, FDA adopted this process as a means to develop and disseminate productspecific 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 the 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 C PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 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: Carbamazepine Cholestyramine Clindamycin HCl D Dinoprostone (multiple RLDs) E Enoxaparin Ethinyl Estradiol Norethindrone Etravirine F Fingolimod I Ibuprofen; Phenlyephrine HCl Imiquimod L Lanthanum Carbonate Loteprednol; Tobramycin M Methylphenidate HCl P Paliperidone Palmitate Podofilox Potassium Chloride (multiple RLDs) Pyridostigmine Bromide T Testosterone E:\FR\FM\22FEN1.SGM 22FEN1

Agencies

[Federal Register Volume 77, Number 35 (Wednesday, February 22, 2012)]
[Notices]
[Pages 10535-10536]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4037]



[[Page 10535]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Final 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 final 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, 
``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: Submit written or electronic comments on Agency guidances at any 
time.

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 recommendations.
    Submit electronic comments to https://www.regulations.gov. Submit 
written comments on product-specific BE recommendations to the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Doan T. Nguyen, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 240-276-8608.

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 https://www.fda.gov/CDER/GUIDANCE/bioequivalence/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, 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. Once finalized, the 
recommendations are posted on FDA's Web site and announced in the 
Federal Register. This notice announces final product-specific 
recommendations that were posted on FDA's Web site in October 2011.
    For a complete history of previous Federal Register notices 
relating to product-specific BE recommendations, please go to https://www.regulations.gov and enter docket number FDA-2007-D-0369.
    These guidances are being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The 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.

II. Drug Products for Which Final Product-Specific BE Recommendations 
are Available

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

A

Acetaminophen; Caffeine; Dihydrocodeine Bitartrate

C

Cephalexin
Ciprofloxacin

D

Desmopressin Acetate

E

Eletriptan HBr

F

Fenoprofen Calcium
Fludrocortisone Acetate

G

Glimepiride; Pioglitazone

H

Hydroxyzine Pamoate (multiple RLDs)

I

Imatinib Mesylate

L

Lansoprazole
Levetiracetam
Linezolid

M

Meprobamate
Methotrexate Sodium (multiple RLDs)
Methylprednisolone Acetate
Metoclopramide HCl

N

Nadolol
Nifedipine
Nilutamide
Nisoldipine
Nitazoxanide
Nitrofurantoin
Nitrofurantoin Macrocrystalline

O

Oxybutynin Chloride

P

Phendimetrazine Tartrate (multiple RLDs)
Phentermine HCl (multiple RLDs)
Phytonadione
Pregabalin
Propafenone HCl
Pyridostigmine Bromide

R

Raltegravir Potassium
Ramelteon

S

Scopolamine
Selegiline
Sorafenib Tosylate

T

Tamoxifen Citrate
Telbivudine
Temazepam
Terbinafine HCl
Toremifene Citrate

V

Voriconazole

Z

Zolpidem

III. 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. 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

[[Page 10536]]

guidance, notices, and received comments are available for public 
examination in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA 
through FDMS only at https://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/CDER/GUIDANCE/bioequivalence/default.htm or 
https://www.regulations.gov.

    Dated: February 14, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4037 Filed 2-21-12; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.