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Final Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled “Bioequivalence Recommendations for Specific Products” explaining the process that would be used to make product-specific BE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.

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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.

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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

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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 Start Printed Page 27150site. 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.

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Dated: May 27, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

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[FR Doc. E9-13261 Filed 6-5-09; 8:45 am]

BILLING CODE 4160-01-S