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Draft and Revised Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations; Availability
A Notice by the Food and Drug Administration on 09/14/2012
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Publication Date:
Agencies:
Department of Health and Human Services
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 November 13, 2012.
Entry Type:
Notice
Action:
Notice.
Document Citation:
77 FR 56851
Page:
56851 -56853 (3 pages)
Agency/Docket Number:
Docket No. FDA-2007-D-0369 (formerly Docket 2007D-0168)
Document Number:
2012-22658
Shorter URL:
https://federalregister.gov/a/2012-22658
Regulations.gov Docket Info
Docket Number
Docket Name
Draft Guidance for Industry Describing Product-Specific Bioequivalence Recommendations
Public Comments
Supporting/Related Materials
Cited References – [Warner Chilcott (US), LLC – Comment] re…
Cited References – [Warner Chilcott (US), LLC – Comment] re…
Attachment 3 – “Exelon Patch (Rivastigmine Transdermal…
Attachment 1 – “Draft Guidance on Rivastigmine” – [Novartis…
Attachment 1 – “Proposed Product-Specific Bioequivalence…
Hyperion Therapeutics – Comment re FDA-2007-D-0369-0040
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 June 11, 2010, FDA announced the availability of a 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. The BE recommendations identified in this notice were developed using the process described in that guidance.
Table of Contents Back to Top
- DATES:
- ADDRESSES:
- FOR FURTHER INFORMATION CONTACT:
- SUPPLEMENTARY INFORMATION:
- I. Background
- II. Drug Products for Which New Draft Product-Specific BE Recommendations Are Available
- A
- B
- C
- D
- E
- F
- K
- L
- M
- N
- O
- P
- R
- S
- T
- III. Drug Products for Which Revised Draft Product-Specific BE Recommendations Are Available
- A
- C
- E
- H
- L
- P
- S
- T
- IV. Comments
- V. Electronic Access
DATES: Back to Top
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 November 13, 2012.
ADDRESSES: Back to Top
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: Back to Top
K. Geoffrey Wu, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9326.
SUPPLEMENTARY INFORMATION: Back to Top
I. Background Back to Top
In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a 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 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 14, 2012 (77 FR 35688). This notice announces draft product-specific recommendations, either new or revised, that are being posted on FDA’s Web site concurrently with publication of this notice.
II. Drug Products for Which New Draft Product-Specific BE Recommendations Are Available Back to Top
FDA is announcing new draft product-specific BE recommendations for drug products containing the following active ingredients:
A Back to Top
Amoxicillin
Amoxicillin; clavulanate potassium
Amphetamine aspartate; amphetamine sulfate; dextroamphetamine saccharate; dextroamphetamine sulfate
B Back to Top
Budesonide
Bupropion hydrochloride (multiple reference listed drugs (RLDs))
C Back to Top
Calcitonin salmon
Carbidopa; levodopa
Carglumic acid
Ciclesonide
Ciprofloxacin; dexamethasone
Cyclophosphamide
D Back to Top
Dalteparin sodium
E Back to Top
Estramustine phosphate sodium
F Back to Top
Fentanyl citrate
K Back to Top
Ketoconazole
L Back to Top
Linagliptin
M Back to Top
Mesalamine (multiple RLDs and dosage forms)
Methylphenidate hydrochloride (multiple RLDs)
N Back to Top
Nifedipine
O Back to Top
Omega-3-acid ethyl esters
Omeprazole
P Back to Top
Paclitaxel
Pazopanib hydrochloride
Progesterone
R Back to Top
Rilpivirine hydrochloride
Roflumilast
S Back to Top
Saxagliptin hydrochloride
T Back to Top
Telaprevir
Tenofovir disoproxil fumarate
Thioguanine
Thalidomide
Tretinoin (multiple RLDs and dosage forms)
III. Drug Products for Which Revised Draft Product-Specific BE Recommendations Are Available Back to Top
FDA is announcing revised draft product-specific BE recommendations for drug products containing the following active ingredients:
A Back to Top
Azacitidine
Azelaic acid
C Back to Top
Capecitabine
E Back to Top
Estrogen, esterified
Etravirine
H Back to Top
Hydrochlorothiazide; losartan potassium
L Back to Top
Lopinavir; ritonavir
P Back to Top
Phytonadione (multiple RLDs and dosage forms)
Propranolol hydrochloride
S Back to Top
Sapropterin dihydrochloride
Sumatriptan
T Back to Top
Tadalafil
Theophylline (multiple RLDs)
Tolterodine tartrate
Topiramate
Trazodone hydrochloride
For a complete history of previously published Federal Register notices related to product-specific BE recommendations, 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). These 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 Back to Top
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 guidances, 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 Back to Top
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: September 4, 2012.
Leslie Kux,
Assistant Commissioner for Policy.