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Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability

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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 In the Federal Register of May 31, 2007 (72 FR 30386), FDA announced the availability of a draft guidance for industry entitled “Bioequivalence Recommendations for Specific Products,” explaining the process that would be used to make product-specific BE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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance recommendations.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 http://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In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled “Bioequivalence Recommendations for Specific Products,” which explained the process that would be used to make product-specific BE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 http://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

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

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

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