Document ID: FDA-2007-D-0369-0018
Agency: fda
Document Type: Notice
Title: Publication of Guidances for Industry Describing Product-Specific Bioequivalence Recommendations
Posted Date: 2008-09-05T04:00Z

[Federal Register: September 5, 2008 (Volume 73, Number 173)]
[Notices]               
[Page 51829-51830]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05se08-59]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369] (formerly Docket No. 2007D-0168)

 
Publication of Guidances for Industry Describing Product-Specific 
Bioequivalence Recommendations

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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May 31, 2007 (72 FR 30388), FDA announced the availability of a draft 
guidance for industry, ``Bioequivalence Recommendations for Specific 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 product-
specific BE recommendations listed in this notice by December 4, 2008.

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

[[Page 51830]]

SUPPLEMENTARY INFORMATION section for electronic access to the draft 
guidance document.

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, 
``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. Since that notice was published we have published a 
correction notice concerning Bioequivalence Recommendations for 
Specific Products on October 25, 2007 (72 FR 60683). This notice 
includes draft product-specific recommendations either newly posted or 
updated since the Federal Register notice dated October 25, 2007, 
through April 30, 2008.

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

    The following draft BE product-specific recommendations have been 
newly posted since the FR notice dated October 25, 2007:
    (1) Abacavir Sulfate; Lamivudine
    (2) Alendronate Sodium
    (3) Alfuzosin HCl
    (4) Alprazolam
    (5) Amoxicillin; Clavulanate Potassium (multiple RLDs)
    (6) Amprenavir
    (7) Aripiprazole
    (8) Armodafinil
    (9) Atovaquone
    (10) Azithromycin
    (11) Balsalazide Disodium
    (12) Bupropion HCl (updated)
    (13) Carbamazepine (multiple dosage forms)
    (14) Cefdinir
    (15) Cefixime
    (16) Cetirizine HCl; Pseudoephedrine HCl
    (17) Ciprofloxacin; Ciprofloxacin HCl
    (18) Ciprofloxacin HCl
    (19) Clarithromycin
    (20) Darunavir Ethanolate
    (21) Delavirdine Mesylate
    (22) Dexmethylphenidate
    (23) Diltiazem HCl (multiple dosage forms; multiple RLDs)
    (24) Divalproex Sodium
    (25) Doxycycline (multiple dosage forms)
    (26) Eprosartan Mesylate; Hydrochlorothiazide
    (27) Esterified Estrogens
    (28) Eszopiclone
    (29) Ethambutol HCl
    (30) Ethinyl Estradiol; Levonorgestrel (multiple RLDs)
    (31) Fenofibrate
    (32) Fluvastatin Sodium (multiple dosage forms)
    (33) Fosamprenavir Calcium
    (34) Glimepiride; Rosiglitazone Maleate
    (35) Lamivudine
    (36) Linezolid
    (37) Lisinopril
    (38) Lopinavir; Ritonavir
    (39) Memantine HCl
    (40) Mesalamine
    (41) Metoprolol Succinate (updated)
    (42) Minocycline HCl
    (43) Nelfinavir Mesylate
    (44) Nevirapine
    (45) Omeprazole; Sodium Bicarbonate; Magnesium Hydroxide
    (46) Oxymorphone HCl (multiple dosage forms)
    (47) Paliperidone
    (48) Paricalcitol
    (49) Phenytoin
    (50) Pimozide
    (51) Posaconazole
    (52) Quinine Sulfate
    (53) Saquinavir Mesylate (multiple dosage forms)
    (54) Solifenacin Succinate
    (55) Tenofovir Disoproxil Fumarate
    (56) Tinidazole
    (57) Tipranavir
    (58) Tolterodine Tartrate
    (59) Tramadol HCl
    (60) Trospium Chloride
    (61) Varenicline Tartrate
    (62) Zafirlukast
    (63) Zalcitabine
    (64) Zileuton
    (65) Zolmitriptan
    (66) Zonisamide

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

    The following five product-specific recommendations previously made 
available on FDA's Web site have been updated:
    1. Risedronate Sodium
    2. Fosinopril Sodium; Hydrochlorothiazide
    3. Fluoxetine HCl; Olanzapine
    4. Erlotinib HCl
    5. Morphine Sulfate
For a complete history of previous Federal Register notices pertaining 
to product-specific BE recommendations, please go to http://
www.regulations.gov and enter FDA-2007-D-0369.

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. Two copies of mailed 
comments are to be submitted, except that individuals may submit one 
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 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 http://www.regulations.gov.

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: August 27, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-20580 Filed 9-4-08; 8:45 am]

BILLING CODE 4160-01-S