Document ID: FDA-2007-D-0369-0025
Agency: fda
Document Type: Notice
Title: Final 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 27148-27150]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08jn09-57]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

 
Final 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 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 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announced the availability of a draft guidance for industry entitled 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 additional draft and revised draft 
product-specific BE recommendations.

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. Submit written comments on the 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 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. Once finalized, the recommendations are posted on FDA's Web 
site and announced in the Federal Register. This notice announces 
product-specific recommendations that have been posted on FDA's Web 
site from May 1, 2008, through October 31, 2008. Additional draft and 
revised draft product-specific BE recommendations are being announced 
elsewhere in this issue of the Federal Register.

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

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

A
Abacavir Sulfate
Abacavir Sulfate; Lamivudine; Zidovudine
Acamprosate Calcium
Acyclovir
Almotriptan Malate
Alosetron HCl
Amlodipine Besylate
Amlodipine Besylate; Benazepril HCl
Amoxicillin; Clavulanate Potassium
Anagrelide HCl
Anastrozole
Aprepitant

[[Page 27149]]

Atazanavir Sulfate
Atomoxetine HCl
Atorvastatin Calcium

B
Benzonatate
Benzphetamine HCl
Bicalutamide
Bisoprolol Fumarate
Bisoprolol Fumarate; Hydrochlorothiazide

C
Candesartan Cilexetil
Carbamazepine
Carvedilol
Cefditoren Pivoxil
Cetirizine HCl
Cevimeline HCl
Cilostazol
Cinacalcet HCl
Clarithromycin
Clonidine HCl

D
Danazol
Darifenacin HBr
Deferasirox
Desloratadine (multiple dosage forms)
Dextromethorphan Polistirex
Diclofenac Sodium; Misoprostol
Dicloxacillin Sodium
Didanosine (multiple dosage forms)
Digoxin
Dipyridamole
Divalproex Sodium
Dofetilide
Donepezil HCl (multiple dosage forms)
Doxazosin Mesylate
Drospirenone; Estradiol
Duloxetine HCl
Dutasteride

E
Efavirenz (multiple dosage forms)
Emtricitabine
Entacapone
Entecavir
Eplerenone
Erlotinib HCl
Escitalopram Oxalate
Esomeprazole Magnesium
Etidronate Disodium
Exemestane

F
Famotidine (multiple dosage forms)
Fenofibrate (multiple dosage forms)
Fluconazole
Fluoxetine HCl; Olanzapine
Fosamprenavir Calcium
Fosinopril Sodium

G
Gabapentin
Gemifloxacin Mesylate
Glimepiride
Glipizide; Metformin HCl
Glyburide; Metformin HCl
Granisetron HCl
H
Hydrochlorothiazide
Hydrochlorothiazide; Irbesartan
Hydrochlorothiazide; Lisinopril
Hydrochlorothiazide; Losartan Potassium
Hydrochlorothiazide; Olmesartan Medoxomil

I
Ibandronate Sodium
Indinavir Sulfate
Irbesartan
Isosorbide Mononitrate
Isradipine (multiple dosage forms)

L
Lamivudine
Lamivudine; Zidovudine
Lamotrigine (multiple dosage forms)
Levonorgestrel
Liothyronine Sodium
Loratadine
Losartan Potassium

M
Mefloquine HCl
Meloxicam (multiple dosage forms)
Mercaptopurine
Metformin HCl
Metformin HCl; Pioglitazone HCl
Miglustat
Mirtazapine
Modafinil
Moexipril HCl

N
Nabumetone
Nateglinide
Nelfinavir Mesylate
Nevirapine

O
Olanzapine
Olmesartan Medoxomil
Olsalazine Sodium
Omeprazole
Omeprazole Magnesium
Omeprazole; Sodium Bicarbonate
Ondansetron
Ondansetron HCl
Oxcarbazepine (multiple dosage forms)

P
Pantoprazole Sodium
Perindopril Erbumine
Phenytoin
Phenytoin Sodium (multiple dosage forms)
Pilocarpine HCl
Pravastatin Sodium

Q
Quetiapine Fumarate
Quinapril HCl

R
Raloxifene HCI
Ramipril
Ribavirin (multiple dosage forms)
Rifampin
Riluzole
Risedronate Sodium; Calcium Carbonate
Ritonavir
Rizatriptan Benzoate
Rosiglitazone Maleate
Rosuvastatin Calcium

S
Sertraline HCl
Sibutramine HCl
Sildenafil Citrate
Simvastatin
Stavudine
Sulfamethoxazole; Trimethoprim
Sumatriptan Succinate

T
Tamsulosin HCl
Telithromycin
Telmisartan
Terazosin HCl
Terbinafine HCl
Testosterone
Ticlopidine HCl
Tizanidine HCl
Tolterodine Tartrate
Torsemide
Tramadol HCl
Tramadol HCl; Acetaminophen
Trandolapril
Triamterene

V
Valacyclovir HCl
Valsartan
Vardenafil HCl
Verapamil HCl (multiple reference listed drug (RLDs))
Voriconazole

Z
Zaleplon
Zidovudine (multiple dosage forms)
Ziprasidone HCl
    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.

III. 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

[[Page 27150]]

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.

IV. 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. E9-13261 Filed 6-5-09; 8:45 am]

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