Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability, 3777-3779 [2012-1433]
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Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices
Any application by Mr. Izurieta for
termination of debarment under section
306(d)(1) (21 U.S.C. 335a(d)(1)) of the
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to the Division of Dockets Management
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Publicly available submissions may
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Monday through Friday.
Dated: January 11, 2012.
Armando Zamora,
Acting Director, Office of Enforcement, Office
of Regulatory Affairs.
[FR Doc. 2012–1489 Filed 1–24–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0369; (Formerly
Docket No. 2007D–0168)]
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 May 31, 2007 (72 FR 30386),
FDA announced the availability of a
draft guidance for industry entitled
‘‘Bioequivalence Recommendations for
Specific Products,’’ explaining 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.
srobinson on DSK4SPTVN1PROD with NOTICES
SUMMARY:
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
DATES:
VerDate Mar<15>2010
18:09 Jan 24, 2012
Jkt 226001
revised draft product-specific BE
recommendations listed in this notice
by March 26, 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:
I. Background
In the Federal Register of May 31,
2007, FDA announced the availability of
a draft 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/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm. As described in that draft
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 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
in the Federal Register of December 1,
2009 (74 FR 62793). This notice
announces draft product-specific
recommendations, either new or
revised, that have been posted on the
PO 00000
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3777
FDA’s Web site in the period from
December 1, 2009, through June 30,
2011.
II. Drug Products for Which New Draft
Product-Specific BE Recommendations
Are Available
FDA is announcing draft BE productspecific recommendations for drug
products containing the following active
ingredients:
A
Acetaminophen
Acetaminophen; Butalbital (multiple
reference listed drugs (RLDs))
Acetaminophen; Butalbital; Caffeine
(multiple RLDs)
Acetaminophen; Hydrocodone Bitartrate
(multiple RLDs)
Acetaminophen Oxycodone (multiple RLDs)
Acetazolamide
Adapalene
Aliskiren Hemifumarate; Valsartan
Altretamine
Amantadine HCl (multiple RLDs)
Amiodarone HCl
Amitriptyline HCl (multiple RLDs)
Amlodipine Besylate; Telmisartan
Amlodipine; Hydrochlorothiazide; Valsartan
Amoxicillin; Clavulanate Potassium
(multiple RLDs)
Aripiprazole
Aspirin; Butalbital; Caffeine (multiple RLDs)
Aspirin; Dipyridamole
Aspirin; Oxycodone
Aspirin; Butalbital; Caffeine; Codeine
Phosphate
Atovaquone
Auranofin
Azelaic Acid (multiple RLDs)
B
Baclofen (multiple RLDs)
Benazepril HCl
Benzoyl Peroxide Clindamycin Phosphate
(multiple RLDs)
Benzoyl Peroxide; Erythromycin (multiple
RLDs)
Betamethasone Acetate; Sodium Phosphate
Betamethasone Dipropionate; Calcipotriene
Hydrate (multiple RLDs)
Betamethasone Dipropionate; Clotrimazole
Betamethasone; Clotrimazole
Bexarotene
Bosentan
Buprenorphine HCl
Buprenorphine HCl; Naloxone HCl
Bupropion HBr
Bupropion HCl
Buspirone
Butoconazole Nitrate (multiple RLDs)
C
Calcipotriene (multiple RLDs)
Carbidopa; Levodopa
Carisoprodol
Carvedilol Phosphate
Cefaclor
Cefadroxil; Cefadroxil Hemihydrate
Cefditoren Pivoxil
Cefixime
Cefuroxime Axetil (multiple RLDs)
Cetirizine HCl
Chlorambucil
Chlorpheniramine Polistirex; Hydrocodone
Polistirex
E:\FR\FM\25JAN1.SGM
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srobinson on DSK4SPTVN1PROD with NOTICES
3778
Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices
Chlorthalidone (multiple RLDs)
Choline Fenofibrate (multiple RLDs)
Ciclopirox (multiple RLDs)
Ciprofloxacin HCl (multiple RLDs)
Clarithromycin
Clindamycin Phosphate (multiple RLDs)
Clobetasol Propionate (multiple RLDs)
Clonazepam
Clonidine
Clotrimazole (multiple RLDs)
Clozapine
Colchicine
Colesevelam HCl
Cyclobenzaprine
D
Dapsone (multiple RLDs)
Darunavir Ethanolate
Dexamethasone
Dexamethasone; Tobramycin
Dexlansoprazole
Diazepam
Diclofenac Potassium
Diclofenac Sodium (multiple RLDs)
Dienogest; Estradiol Valerate
Diethylpropion
Diphenhydramine; Ibuprofen
Disulfiram (multiple RLDs)
Divalproex Sodium
Dolasetron Mesylate
Donepezil HCl
Doxazosin Mesylate
Doxepin HCl (multiple RLDs)
Doxorubicin HCl
Dronabinol
Dronedarone HCl
E
Econazole Nitrate
Ergocalciferol
Erythromycin (multiple RLDs)
Erythromycin Ethylsuccinate; Sulfisoxazole
Acetyl
Esomeprazole Magnesium
Esomeprazole Magnesium; Naproxen
Estradiol (multiple RLDs)
Estrogens Conjugated Synthetic A
Ethacrynic Acid
Ethinyl Estradiol; Norethindrone
Ethinyl Estradiol; Norethindrone Acetate
Ethinyl Estradiol; Norgestimate (multiple
RLDs)
Etodolac
Etoposide
Everolimus
F
Febuxostat
Felodipine
Fenofibrate
Fenofibric Acid
Fentanyl Citrate
Fesoterodine Fumarate
Finasteride
Flucytosine
Fluorouracil (multiple RLDs)
Fluoxetine HCl (multiple RLDs)
Fluticasone Propionate
Fluvoxamine Maleate
Furosemide
G
Galantamine HBr
Gemfibrozil
Glipizide
Griseofulvin
Griseofulvin Microcrystalline
Guanfacine HCl
VerDate Mar<15>2010
18:09 Jan 24, 2012
Jkt 226001
H
Hydrochlorothiazide; Moexipril
Hydrochlorothiazide; Spironolactone
Homatropine Methylbromide; Hydrocodone
Bitartrate
Hydralazine; Isosorbide
Hydrochlorothiazide
Hydrochlorothiazide; Quinapril HCl
Hydrocodone; Ibuprofen (multiple RLDs)
Hydromorphone HCl
Hydroxychloroquine
Hydroxyzine HCl (multiple RLDs)
I
Ibuprofen (multiple RLDs)
Iloperidone
Imipramine Pamoate
Imiquimod (multiple RLDs)
Indomethacin (multiple RLDs)
K
Ketoconazole
L
Labetalol HCl
Lamotrigine
Lansoprazole
Lapatinib Ditosylate
Lenalidomide
Leuprolide Acetate (multiple RLDs)
Levetiracetam
Levonorgestrel
Lithium Carbonate (multiple RLDs)
Loratadine; Pseudoephedrine Sulfate
Lorazepam
Loteprednol
Lubiprostone
M
Maraviroc
Meclizine
Meclizine HCl
Mefenamic Acid
Megestrol Acetate (multiple RLDs)
Mestranol; Norethindrone
Metformin HCl; Pioglitazone HCl
Methimazole
Methoxsalen (multiple RLDs)
Methylphenidate
Methylphenidate HCl
Methylprednisolone
Metoclopramide HCl
Metolazone
Metoprolol Tartrate; Hydrochlorothiazide
Metronidazole (multiple RLDs)
Mifepristone
Milnacipran HCl
Minocycline HCl
Minoxidil (multiple RLDs)
Mirtazapine
Misoprostol
Molindone HCl
Morphine Sulfate (multiple RLDs)
Mupirocin
Mupirocin Calcium (multiple RLDs)
Mycophenolate Mofetil
N
Naltrexone HCl
Naproxen
Naproxen Sodium
Naproxen Sodium; Sumatriptan Succinate
Nebivolol
Niacin; Simvastatin
Nicotine Polacrilex
Nifedipine
Nilotinib HCl Monohydrate
Nitroglycerin (multiple RLDs)
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
Nystatin (multiple RLDs)
O
Octreotide
Ofloxacin
Orlistat (multiple RLDs)
Orphenadrine Citrate
Oseltamivir Phosphate (multiple RLDs)
Oxybutynin
Oxycodone
Oxycodone HCl (multiple RLDs)
Oxymetholone
P
Palonosetron HCl
Pantoprazole Sodium
Paroxetine
Penbutolol
Penicillin V Potassium
Perphenazine (multiple RLDs)
Phenelzine Sulfate
Phytonadione
Pioglitazone HCl
Pitavastatin
Potassium Citrate
Pramipexole Dihydrochloride
Prasugrel HCl
Prednisolone Acetate
Progesterone
Promethazine HCl (multiple RLDs)
Propafenone HCl
Propranolol HCl
Protriptyline HCl
Pseudoephedrine HCl
R
Rabeprazole Sodium
Ranitidine HCl
Ranolazine
Rifabutin
Risedronate
Risperidone (multiple RLDs)
Ritonavir
Rivastigmine
Ropinirole HCl
S
Sevelamer Carbonate
Sitagliptin Phosphate
Sotalol (multiple RLDs)
Spironolactone
Sulfacetamide Sodium
Sulfasalazine (multiple RLDs)
Sunitinib Malate
T
Tapentadol HCl
Tazarotene (multiple RLDs)
Terbinafine HCl
Terconazole (multiple RLDs)
Tetracycline
Theophylline (multiple RLDs)
Tioconazole
Tizanidine HCl
Topotecan
Tranexamic Acid
Trazodone HCl (multiple RLDs)
Tretinoin
Triamcinolone Acetonide (multiple RLDs)
Triazolam
Trimethoprim
U
Ursodiol
V
Valproic Acid
Venlafaxine HCl
Verapamil HCl
E:\FR\FM\25JAN1.SGM
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Federal Register / Vol. 77, No. 16 / Wednesday, January 25, 2012 / Notices
W
Warfarin Sodium
Z
Zolmitriptan
Zolpidem
srobinson on DSK4SPTVN1PROD with NOTICES
III. Drug Products for Which Revised
Draft Product-Specific BE
Recommendations Are Available
FDA is announcing revised draft BE
product-specific recommendations for
drug products containing the following
active ingredients. These
recommendations were previously
posted on the FDA’s Web site:
A
Amantadine HCl
Atorvastatin
B
Bupropion HBr
C
Calcipotriene
Calcium Acetate
Calcitriol
Capecitabine (multiple RLDs)
Cefditoren Pivoxil
Ciclopirox
Clotrimazole
Colesevelam HCl (multiple RLDs)
D
Darunavir Ethanolate
Desogestrel; Ethinyl Estradiol
Desvenlafaxine Succinate
Diclofenac Sodium
Diclofenac Sodium; Misoprostol
Disulfiram
Donepezil HCl (multiple RLDs)
E
Emtricitabine
Esomeprazole Magnesium
Estradiol
Ethinyl Estradiol; Ethynodiol Diacetate
(multiple RLDs)
Ethinyl Estradiol; Norethindrone
F
Felbamate (multiple RLDs)
Fentanyl
Fentanyl Citrate
Fluorouracil (multiple RLDs)
G
Glyburide Metformin
Granisetron HCl
L
Labetalol HCl
Lamotrigine (multiple RLDs)
Lapatinib Ditosylate
Levofloxacin
Levonorgestrel (multiple RLDs)
Linezolid
M
Memantine HCl
Mercaptopurine (multiple RLDs)
Metformin HCl (multiple RLDs)
Minoxidil
Morphine
N
Nebivolol
Niacin
VerDate Mar<15>2010
18:09 Jan 24, 2012
Jkt 226001
Nilutamide
Nitroglycerin
O
Omeprazole
Orlistat (multiple RLDs)
Oxymorphone HCl
P
Prednisolone
Progesterone
R
Rivastigmine
Rivastigmine Tartrate
Ropinirole
S
Scopolamine
Sevelamer Carbonate (multiple RLDs)
Sevelamer HCl (multiple RLDs)
Sirolimus
T
Telmisartan
Tiagabine HCl
Topiramate
Tranexamic Acid
Triamcinolone Acetonide (multiple RLDs)
V
Varenicline Tartrate
Venlafaxine HCl
For a complete history of previously
published Federal Register notices,
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.
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. 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
guidance, 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
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
3779
default.htm or https://
www.regulations.gov.
Dated: January 19, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012–1433 Filed 1–24–12; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1999–D–4079 (Formerly
Docket No. 1999D–0254)]
Guidance for Industry on Product
Name Placement, Size, and
Prominence in Advertising and
Promotional Labeling; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance document
entitled ‘‘Product Name Placement,
Size, and Prominence in Advertising
and Promotional Labeling.’’ The
guidance is intended to clarify for
applicants the requirements for product
name placement, size, prominence, and
frequency in promotional labeling and
advertising for prescription human and
animal drugs and biological products.
This guidance finalizes the draft
guidance published in January 1999.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the guidance 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; or Office
of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance
document.
Submit electronic comments on the
guidance 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:
SUMMARY:
E:\FR\FM\25JAN1.SGM
25JAN1
]]>Agencies
[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3777-3779]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1433]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369; (Formerly Docket No. 2007D-0168)]
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
May 31, 2007 (72 FR 30386), FDA announced the availability of a draft
guidance for industry entitled ``Bioequivalence Recommendations for
Specific Products,'' explaining 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 March 26, 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 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:
I. Background
In the Federal Register of May 31, 2007, FDA announced the
availability of a draft 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/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. As
described in that draft 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 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 in the Federal Register of
December 1, 2009 (74 FR 62793). 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 December 1, 2009, through June
30, 2011.
II. Drug Products for Which New Draft Product-Specific BE
Recommendations Are Available
FDA is announcing draft BE product-specific recommendations for
drug products containing the following active ingredients:
A
Acetaminophen
Acetaminophen; Butalbital (multiple reference listed drugs (RLDs))
Acetaminophen; Butalbital; Caffeine (multiple RLDs)
Acetaminophen; Hydrocodone Bitartrate (multiple RLDs)
Acetaminophen Oxycodone (multiple RLDs)
Acetazolamide
Adapalene
Aliskiren Hemifumarate; Valsartan
Altretamine
Amantadine HCl (multiple RLDs)
Amiodarone HCl
Amitriptyline HCl (multiple RLDs)
Amlodipine Besylate; Telmisartan
Amlodipine; Hydrochlorothiazide; Valsartan
Amoxicillin; Clavulanate Potassium (multiple RLDs)
Aripiprazole
Aspirin; Butalbital; Caffeine (multiple RLDs)
Aspirin; Dipyridamole
Aspirin; Oxycodone
Aspirin; Butalbital; Caffeine; Codeine Phosphate
Atovaquone
Auranofin
Azelaic Acid (multiple RLDs)
B
Baclofen (multiple RLDs)
Benazepril HCl
Benzoyl Peroxide Clindamycin Phosphate (multiple RLDs)
Benzoyl Peroxide; Erythromycin (multiple RLDs)
Betamethasone Acetate; Sodium Phosphate
Betamethasone Dipropionate; Calcipotriene Hydrate (multiple RLDs)
Betamethasone Dipropionate; Clotrimazole
Betamethasone; Clotrimazole
Bexarotene
Bosentan
Buprenorphine HCl
Buprenorphine HCl; Naloxone HCl
Bupropion HBr
Bupropion HCl
Buspirone
Butoconazole Nitrate (multiple RLDs)
C
Calcipotriene (multiple RLDs)
Carbidopa; Levodopa
Carisoprodol
Carvedilol Phosphate
Cefaclor
Cefadroxil; Cefadroxil Hemihydrate
Cefditoren Pivoxil
Cefixime
Cefuroxime Axetil (multiple RLDs)
Cetirizine HCl
Chlorambucil
Chlorpheniramine Polistirex; Hydrocodone Polistirex
[[Page 3778]]
Chlorthalidone (multiple RLDs)
Choline Fenofibrate (multiple RLDs)
Ciclopirox (multiple RLDs)
Ciprofloxacin HCl (multiple RLDs)
Clarithromycin
Clindamycin Phosphate (multiple RLDs)
Clobetasol Propionate (multiple RLDs)
Clonazepam
Clonidine
Clotrimazole (multiple RLDs)
Clozapine
Colchicine
Colesevelam HCl
Cyclobenzaprine
D
Dapsone (multiple RLDs)
Darunavir Ethanolate
Dexamethasone
Dexamethasone; Tobramycin
Dexlansoprazole
Diazepam
Diclofenac Potassium
Diclofenac Sodium (multiple RLDs)
Dienogest; Estradiol Valerate
Diethylpropion
Diphenhydramine; Ibuprofen
Disulfiram (multiple RLDs)
Divalproex Sodium
Dolasetron Mesylate
Donepezil HCl
Doxazosin Mesylate
Doxepin HCl (multiple RLDs)
Doxorubicin HCl
Dronabinol
Dronedarone HCl
E
Econazole Nitrate
Ergocalciferol
Erythromycin (multiple RLDs)
Erythromycin Ethylsuccinate; Sulfisoxazole Acetyl
Esomeprazole Magnesium
Esomeprazole Magnesium; Naproxen
Estradiol (multiple RLDs)
Estrogens Conjugated Synthetic A
Ethacrynic Acid
Ethinyl Estradiol; Norethindrone
Ethinyl Estradiol; Norethindrone Acetate
Ethinyl Estradiol; Norgestimate (multiple RLDs)
Etodolac
Etoposide
Everolimus
F
Febuxostat
Felodipine
Fenofibrate
Fenofibric Acid
Fentanyl Citrate
Fesoterodine Fumarate
Finasteride
Flucytosine
Fluorouracil (multiple RLDs)
Fluoxetine HCl (multiple RLDs)
Fluticasone Propionate
Fluvoxamine Maleate
Furosemide
G
Galantamine HBr
Gemfibrozil
Glipizide
Griseofulvin
Griseofulvin Microcrystalline
Guanfacine HCl
H
Hydrochlorothiazide; Moexipril
Hydrochlorothiazide; Spironolactone
Homatropine Methylbromide; Hydrocodone Bitartrate
Hydralazine; Isosorbide
Hydrochlorothiazide
Hydrochlorothiazide; Quinapril HCl
Hydrocodone; Ibuprofen (multiple RLDs)
Hydromorphone HCl
Hydroxychloroquine
Hydroxyzine HCl (multiple RLDs)
I
Ibuprofen (multiple RLDs)
Iloperidone
Imipramine Pamoate
Imiquimod (multiple RLDs)
Indomethacin (multiple RLDs)
K
Ketoconazole
L
Labetalol HCl
Lamotrigine
Lansoprazole
Lapatinib Ditosylate
Lenalidomide
Leuprolide Acetate (multiple RLDs)
Levetiracetam
Levonorgestrel
Lithium Carbonate (multiple RLDs)
Loratadine; Pseudoephedrine Sulfate
Lorazepam
Loteprednol
Lubiprostone
M
Maraviroc
Meclizine
Meclizine HCl
Mefenamic Acid
Megestrol Acetate (multiple RLDs)
Mestranol; Norethindrone
Metformin HCl; Pioglitazone HCl
Methimazole
Methoxsalen (multiple RLDs)
Methylphenidate
Methylphenidate HCl
Methylprednisolone
Metoclopramide HCl
Metolazone
Metoprolol Tartrate; Hydrochlorothiazide
Metronidazole (multiple RLDs)
Mifepristone
Milnacipran HCl
Minocycline HCl
Minoxidil (multiple RLDs)
Mirtazapine
Misoprostol
Molindone HCl
Morphine Sulfate (multiple RLDs)
Mupirocin
Mupirocin Calcium (multiple RLDs)
Mycophenolate Mofetil
N
Naltrexone HCl
Naproxen
Naproxen Sodium
Naproxen Sodium; Sumatriptan Succinate
Nebivolol
Niacin; Simvastatin
Nicotine Polacrilex
Nifedipine
Nilotinib HCl Monohydrate
Nitroglycerin (multiple RLDs)
Nystatin (multiple RLDs)
O
Octreotide
Ofloxacin
Orlistat (multiple RLDs)
Orphenadrine Citrate
Oseltamivir Phosphate (multiple RLDs)
Oxybutynin
Oxycodone
Oxycodone HCl (multiple RLDs)
Oxymetholone
P
Palonosetron HCl
Pantoprazole Sodium
Paroxetine
Penbutolol
Penicillin V Potassium
Perphenazine (multiple RLDs)
Phenelzine Sulfate
Phytonadione
Pioglitazone HCl
Pitavastatin
Potassium Citrate
Pramipexole Dihydrochloride
Prasugrel HCl
Prednisolone Acetate
Progesterone
Promethazine HCl (multiple RLDs)
Propafenone HCl
Propranolol HCl
Protriptyline HCl
Pseudoephedrine HCl
R
Rabeprazole Sodium
Ranitidine HCl
Ranolazine
Rifabutin
Risedronate
Risperidone (multiple RLDs)
Ritonavir
Rivastigmine
Ropinirole HCl
S
Sevelamer Carbonate
Sitagliptin Phosphate
Sotalol (multiple RLDs)
Spironolactone
Sulfacetamide Sodium
Sulfasalazine (multiple RLDs)
Sunitinib Malate
T
Tapentadol HCl
Tazarotene (multiple RLDs)
Terbinafine HCl
Terconazole (multiple RLDs)
Tetracycline
Theophylline (multiple RLDs)
Tioconazole
Tizanidine HCl
Topotecan
Tranexamic Acid
Trazodone HCl (multiple RLDs)
Tretinoin
Triamcinolone Acetonide (multiple RLDs)
Triazolam
Trimethoprim
U
Ursodiol
V
Valproic Acid
Venlafaxine HCl
Verapamil HCl
[[Page 3779]]
W
Warfarin Sodium
Z
Zolmitriptan
Zolpidem
III. Drug Products for Which Revised Draft Product-Specific BE
Recommendations Are Available
FDA is announcing revised draft BE product-specific recommendations
for drug products containing the following active ingredients. These
recommendations were previously posted on the FDA's Web site:
A
Amantadine HCl
Atorvastatin
B
Bupropion HBr
C
Calcipotriene
Calcium Acetate
Calcitriol
Capecitabine (multiple RLDs)
Cefditoren Pivoxil
Ciclopirox
Clotrimazole
Colesevelam HCl (multiple RLDs)
D
Darunavir Ethanolate
Desogestrel; Ethinyl Estradiol
Desvenlafaxine Succinate
Diclofenac Sodium
Diclofenac Sodium; Misoprostol
Disulfiram
Donepezil HCl (multiple RLDs)
E
Emtricitabine
Esomeprazole Magnesium
Estradiol
Ethinyl Estradiol; Ethynodiol Diacetate (multiple RLDs)
Ethinyl Estradiol; Norethindrone
F
Felbamate (multiple RLDs)
Fentanyl
Fentanyl Citrate
Fluorouracil (multiple RLDs)
G
Glyburide Metformin
Granisetron HCl
L
Labetalol HCl
Lamotrigine (multiple RLDs)
Lapatinib Ditosylate
Levofloxacin
Levonorgestrel (multiple RLDs)
Linezolid
M
Memantine HCl
Mercaptopurine (multiple RLDs)
Metformin HCl (multiple RLDs)
Minoxidil
Morphine
N
Nebivolol
Niacin
Nilutamide
Nitroglycerin
O
Omeprazole
Orlistat (multiple RLDs)
Oxymorphone HCl
P
Prednisolone
Progesterone
R
Rivastigmine
Rivastigmine Tartrate
Ropinirole
S
Scopolamine
Sevelamer Carbonate (multiple RLDs)
Sevelamer HCl (multiple RLDs)
Sirolimus
T
Telmisartan
Tiagabine HCl
Topiramate
Tranexamic Acid
Triamcinolone Acetonide (multiple RLDs)
V
Varenicline Tartrate
Venlafaxine HCl
For a complete history of previously published Federal Register
notices, 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.
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. 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
guidance, 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 https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: January 19, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-1433 Filed 1-24-12; 8:45 am]
BILLING CODE 4160-01-P
