Document ID: FDA-2007-D-0369-0033
Agency: fda
Document Type: Notice
Title: Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
Posted Date: 2009-12-01T05:00Z

[Federal Register: December 1, 2009 (Volume 229, Number 74)]
[Notices]               
[Page 62793-62795]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01de09-77]                         

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

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May 31, 2007, FDA announced the availability of a draft guidance for 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:  Submit written or electronic comments on the draft and revised 
draft product-specific BE recommendations listed in this notice by 
February 1, 2010.

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 
draft guidance 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 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 
June 8, 2009 (74 FR 27146). This notice announces draft product-
specific recommendations, either new or revised, that have been posted 
on FDA's Web site in the period from November 1, 2008, through December 
1, 2009.

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
Adapalene (multiple reference listed drugs (RLDs))
Adapalene; Benzoyl Peroxide
Alendronate Sodium; Cholecalciferol
Aliskiren Hemifumarate
Aliskiren Hemifumarate; Hydrochlorothiazide
Allopurinol
Ambrisentan
Amlodipine Besylate; Atorvastatin Calcium
Atenolol
B
Bromfenac Sodium
Bromocriptine
Budesonide

C
Calcium Acetate
Cephalexin
Chlorpheniramine Polistirex; Hydrocodone Polistirex
Ciprofloxacin
Clonidine
Clotrimazole (multiple RLDs)

D
Desmopressin Acetate
Desogestrel; Ethinyl Estradiol (multiple RLDs)
Desvenlafaxine Succinate
Dextroamphetamine Sulfate
Dextromethorphan Hydrobromide; Guaifenesin
Diclofenac Sodium (multiple RLDs)
Doxycycline Hyclate
Drospirenone; Ethinyl Estradiol

E
Eletriptan Hydrobromide

[[Page 62794]]

Estradiol (multiple RLDs)
Ethinyl Estradiol; Levonorgestrel (multiple RLDs)
Ethinyl Estradiol; Norelgestromin
Ethinyl Estradiol; Norethindrone Acetate (multiple RLDs)
Ethinyl Estradiol; Norgestrel (multiple RLDs)

F
Famotidine
Felodipine
Fenoprofen Calcium
Fentanyl
Fexofenadine HCl
Fexofenadine; Pseudoephedrine (multiple RLDs)
Fludrocortisone Acetate

G
Glimepiride; Pioglitazone HCl
Glycopyrrolate
Guaifenesin; Pseudoephedrine HCl

H
Haloperidol
Hydrocodone Bitartrate; Acetaminophen
Hydroxyzine Pamoate (multiple RLDs)

I
Imatinib Mesylate

L
Lansoprazole
Levetiracetam
Linezolid
Loratadine

M
Meprobamate
Metformin HCl (multiple RLDs)
Metformin HCl; Repaglinide
Methotrexate Sodium (multiple RLDs)
Metoclopramide HCl
Miconazole Nitrate (multiple RLDs)
Mycophenolic Acid

N
Nadolol
Naltrexone
Niacin
Nifedipine
Nilutamide
Nisoldipine
Nitazoxanide
Nitrofurantoin
Nitrofurantoin Macrocrystalline
Norethindrone
Norethindrone Acetate

O
Oxybutynin Chloride

P
Phendimetrazine Tartrate (multiple RLDs)
Phentermine HCl (multiple RLDs)
Phytonadione
Pramipexole Dihydrochloride
Prednisolone
Pregabalin
Propafenone HCl
Pyridostigmine Bromide

R
Raltegravir Potassium
Ramelteon
Raniditine (multiple RLDs)
Rasagiline Mesylate
Rivastigmine Tartrate

S
Scopolamine
Selegiline
Sodium Phenylbutyrate (multiple RLDs)
Sorafenib Tosylate

T
Tamoxifen Citrate
Telbivudine
Temazepam
Terbinafine HCl
Toremifene Citrate
Trandolapril; Verapamil HCl
Triamcinolone Acetonide (multiple RLDs)

V
Voriconazole

Z
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 FDA's Web site:

A
Azacitidine

B
Busulfan

C
Carbidopa; Entacapone; Levodopa

D
Darunavir Ethanolate
Desogestrel; Ethinyl Estradiol
Doxercalciferol

E
Ethinyl Estradiol; Norethindrone (multiple RLDs)

F
Fluoxetine HCl; Olanzapine

H
Hydrochlorothiazide; Lisinopril

I
Ibuprofen

L
Lansoprazole
Lovastatin; Niacin

M
Methylprednisolone Acetate
Melphalan

N
Nabilone

O
Omeprazole; Sodium Bicarbonate

Q
Quetiapine Fumarate

R
Risedronate Sodium

S
Sevelamer Carbonate
Sevelamer HCl
Sildenafil Citrate

T
Temozolomide
Topiramate
Tacrolimus

    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 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/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

[[Page 62795]]

    Dated: November 20, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-28593 Filed 11-30-09; 8:45 am]

BILLING CODE 4160-01-S