Document ID: FDA-2007-D-0369-0026
Agency: fda
Document Type: Notice
Title: Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
Posted Date: 2009-06-08T04:00Z

[Federal Register: June 8, 2009 (Volume 74, Number 108)]
[Notices]               
[Page 27146-27148]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn09-56]                         

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369] (formerly Docket No. 2007D-0169)

 
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May 31, 2007, FDA announced the availability of a draft guidance for 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. Elsewhere in this issue of the 
Federal Register, FDA is announcing the availability of final product-
specific BE recommendations.

DATES: Submit written or electronic comments on the draft and revised 
draft product-specific BE recommendations listed in this notice by 
September 8, 2009.

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

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, 240-276-9314.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of May 31, 2007 (72 FR 30388), FDA 
announced the availability of a draft 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/cder/guidance/bioequivalence/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

[[Page 27147]]

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 90 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 September 5, 2008 (73 FR 
51829). This notice announces draft product-specific recommendations, 
either new or revised, that have been posted on FDA's Web site in the 
period from May 1, 2008, through October 31, 2008. Final product-
specific recommendations are being announced elsewhere in this issue of 
the Federal Register.

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

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

A
Acetazolamide
Adefovir Dipivoxil
Albuterol Sulfate
Aliskiren Hemifumarate
Alprazolam
Aminosalicylic Acid
Amlodipine Besylate; Olmesartan Medoxomil
Amlodipine Besylate; Valsartan
Amprenavir
Atovaquone; Proguanil
Azacitidine
Azithromycin

B
Baclofen
Bethanechol Chloride
Bismuth Subcitrate Potassium; Metronidazole; Tetracycline HCl
Brimonidine Tartrate
Bumetanide
Busulfan

C
Calcitriol
Capecitabine
Citalopram HBr (multiple dosage forms)
Clotrimazole
Colesevelam HCl
Cyclobenzaprine HCl

D
Demeclocycline HCl
Desogestrel; Ethinyl Estradiol
Diflunisal
Disopyramide Phosphate (multiple dosage forms)
Doxercalciferol
Doxycycline
Doxycycline Hyclate

E
Efavirenz; Emtricitabine; Tenofovir Disoproxil Fumarate
Enalapril Maleate
Eprosartan Mesylate
Escitalopram Oxalate
Ethinyl Estradiol; Levonorgestrel
Ethinyl Estradiol; Norethindrone Acetate (multiple reference listed 
drugs (RLDs))
Ethosuximide
Ezetimibe; Simvastatin
Ezetimibe

F
Famciclovir
Fenofibrate (multiple dosage forms)
Fexofenadine HCl
Frovatriptan Succinate

G
Gatifloxacin
Glipizide
Goserelin Acetate
Griseofulvin, Ultramicrocrystalline

H
Hydrochlorothiazide; Telmisartan
Hydrochlorothiazide; Triamterene
Hydralazine HCl
Hydroxyurea

I
Ibuprofen (multiple dosage forms)
Indapamide
Isoniazid
Isotretinoin

K
Ketoconazole
Ketorolac Tromethamine

L
Lansoprazole
Latanoprost
Letrozole
Leucovorin Calcium
Leuprolide Acetate
Levocetirizine Dihydrochloride
Levofloxacin
Lisdexamfetamine Dimesylate
Lithium Carbonate
Lopinavir; Ritonavir
Loratadine

M
Mebendazole
Melphalan
Metformin HCl
Methadone HCl
Midodrine HCl
Minocycline HCl
Montelukast
Montelukast Sodium
Moxifloxacin HCl

N
Nabilone
Naltrexone HCl
Naproxen Sodium (multiple RLDs)
Naratriptan HCl
Nicardipine HCl

O
Olanzapine
Olopatadine HCl
Omeprazole; Sodium Bicarbonate

P
Paroxetine HCl
Penicillamine
Phenoxybenzamine HCl
Prednisolone Sodium Phosphate

Q
Quetiapine Fumarate

R
Ramipril
Repaglinide

S
Sapropterin Dihydrochloride
Selegiline HCl
Sevelamer Carbonate
Sevelamer HCl
Simvastatin
Sitagliptin Phosphate; Metformin HCl
Sodium Iodide
Stavudine
Sulfadiazine
Sulfamethoxazole; Trimethoprim

T
Theophylline
Tiagabine HCl
Triptorelin Pamoate
Trospium Cl

U
Ursodiol

V
Valganciclovir HCl
Verapamil HCl
Vorinostat

Z
Zileuton
Ziprasidone HCl

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 FDA's Web site.

A
Alprazolam

C
Candesartan Cilexetil; Hydrochlorothiazide
Carbidopa; Entacapone; Levodopa
Clopidogrel Bisulfate

F
Fexofenadine HCl (multiple dosage forms)
Fosinopril Sodium; Hydrochlorothiazide

[[Page 27148]]

H
Hydrochlorothiazide; Valsartan

M
Minoxidil
Montelukast Sodium
Morphine Sulfate

S
Sirolimus

Z
Zolmitriptan
    For a complete history of previously published Federal Register 
notices, please go to http://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.

IV. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments on any of the specific 
BE recommendations posted on FDA's Web site. Submit a single copy of 
electronic comments or two paper copies of any mailed comments, except 
that individuals may submit one paper copy. Comments are to be 
identified 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 http://www.fda.gov/cder/guidance/index.htm or http://
www.regulations.gov.

    Dated: May 27, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-13272 Filed 6-5-09; 8:45 am]

BILLING CODE 4160-01-S