E9-28593. 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 In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled “Bioequivalence Recommendations for Specific Products,” explaining the process that would be used to make product-specific BE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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance recommendations.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In the Federal Register of May 31, 2007 (72 FR 30388), FDA announced the availability of a draft guidance for industry entitled “Bioequivalence Recommendations for Specific Products,” that explained the process that would be used to make product-specific BE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 As described in that draft guidance, FDA adopted this process as a means to develop and disseminate product-specific BE recommendations and provide a meaningful opportunity for the public to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

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.

Dated: November 20, 2009.

David Horowitz,

Assistant Commissioner for Policy.