Federal Register: December 1, 2009 (Volume 74, Number 229)
DOCID: fr01de09-77 FR Doc E9-28593
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket ID: [Docket No. FDA-2007-D-0369] (formerly Docket No. 2007D-0168)
NOTICE: NOTICES
DOCID: fr01de09-77
DOCUMENT ACTION: Notice.
SUBJECT CATEGORY:
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
DATES: Submit written or electronic comments on the draft and revised draft productspecific BE recommendations listed in this notice by February 1, 2010.
DOCUMENT SUMMARY:
The Food and Drug Administration (FDA) is announcing the availability of additional draft and revised draft productspecific bioequivalence (BE) recommendations. The recommendations provide productspecific 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 In the Federal Register of May 31, 2007, FDA announced the availability of a draft guidance for industry entitled ``Bioequivalence Recommendations for Specific Products,'' explaining the process that would be used to make product specific BE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.
SUMMARY:
Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
SUPPLEMENTAL 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announced the availability of a draft guidance for industry entitled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 productspecific 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that draft guidance, FDA adopted this process as a means to develop and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 productspecific 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 ProductSpecific BE
Recommendations Are Available
FDA is announcing draft BE productspecific 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 ProductSpecific BE Recommendations Are Available
FDA is announcing revised draft BE productspecific 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 FDA2007D0369.
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 productspecific 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. E928593 Filed 113009; 8:45 am]
BILLING CODE 416001S
FOR FURTHER INFORMATION CONTACT
Doan T. Nguyen, Center for Drug Evaluation and Research (HFD600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 2402769314.