Bioequivalence Recommendations for Clozapine Orally Disintegrating Tablets/Oral; Draft Guidance for Industry; Availability, 26063-26064 [2015-10478]

Download as PDF Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices Veterinary Medicine (CVM), as part of an NADA or ANADA, respectively. CVM encourages sponsors to submit data for review at the most appropriate and productive times in the drug development process. Rather than submitting all data for review as part of a complete application, we have found that the submission of data supporting discrete technical sections during the investigational phase of the new animal drug is the most appropriate and productive. This ‘‘phased review’’ of data submissions has created efficiencies for CVM and the animal pharmaceutical industry. These increased efficiencies have facilitated the approval of both pioneer and generic new animal drugs. This guidance defines what an administrative (A)NADA is, defines and describes the phased review process, and briefly discusses how sponsors should submit an administrative (A)NADA and the time frame for review. II. Significance of Guidance This level 1 guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on Administrative Applications and the Phased Review Process. It does establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. tkelley on DSK3SPTVN1PROD with NOTICES III. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501– 3520). The collections of information in 21 CFR part 514 have been approved under OMB control number 0910–0032. The collections of information in section 512(n)(1) of the FD&C Act have been approved under OMB control number 0910–0669. IV. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and VerDate Sep<11>2014 18:43 May 05, 2015 Jkt 235001 26063 will be posted to the docket at https:// www.regulations.gov. Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. V. Electronic Access FOR FURTHER INFORMATION CONTACT: Persons with access to the Internet may obtain the guidance at either https://www.fda.gov/AnimalVeterinary/ GuidanceComplianceEnforcement/ GuidanceforIndustry/default.htm or https://www.regulations.gov. Xiaoqiu Tang, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993–0002, 301– 796–5850. Dated: April 30, 2015. Leslie Kux, Associate Commissioner for Policy. I. Background [FR Doc. 2015–10480 Filed 5–5–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–D–1378] Bioequivalence Recommendations for Clozapine Orally Disintegrating Tablets/Oral; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Bioequivalence Recommendations for Clozapine,’’ for the orally disintegrating tablets (ODTs). The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for clozapine ODTs. 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 comment on the draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 6, 2015. ADDRESSES: Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, 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 documents. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug SUMMARY: PO 00000 Frm 00069 Fmt 4703 Sfmt 4703 SUPPLEMENTARY INFORMATION: In the Federal Register of June 11, 2010 (75 FR 33311), FDA announced the availability of a guidance for industry, ‘‘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 https://www.fda.gov/Drugs/ GuidanceComplianceRegulatory Information/Guidances/default.htm. As described in that 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. This notice announces the availability of one draft BE recommendation for clozapine ODTs. Clozapine tablets, marketed under the name CLOZARIL, are the subject of new drug application (NDA) 19–758, held by Novartis Pharmaceuticals Corporation and approved by FDA on September 26, 1989. FazaClo ODTs were approved by FDA on February 19, 2004, under NDA 21–590, currently held by Jazz Pharmaceuticals III International LTD, based upon a finding that FazaClo ODTs were bioequivalent to CLOZARIL immediate-release tablets. FazaClo ODTs are available as yellow, orally disintegrating tablets of 12.5, 25, 100, 150, and 200 1 milligrams (mg) of clozapine for oral administration without water. They are formulated to disintegrate once exposed to saliva and then are easily swallowed. In June 2005, FDA published a guidance for industry entitled ‘‘Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution Testing’’ (Clozapine Guidance) (70 FR 35447, June 20, 2005), which replaced a 1996 product-specific bioequivalence guidance for clozapine tablets. The 2005 Clozapine Guidance recommends that ANDA applicants employ multipledose, steady-state studies to evaluate the 1 FDA approved the supplemental NDA for the 150 and 200 mg strengths on July 9, 2010. E:\FR\FM\06MYN1.SGM 06MYN1 26064 Federal Register / Vol. 80, No. 87 / Wednesday, May 6, 2015 / Notices bioequivalence of clozapine products.2 FDA recommends that such studies be performed only in patients who have not responded well to standard antipsychotic drug treatment and who have been receiving a maintenance dose of an approved clozapine product for at least 3 months. FDA is now issuing a draft guidance for industry on BE recommendations for generic clozapine that applies specifically to the ODTs. Beckloff Associates, Inc., filed a citizen petition in December 2007, a citizen petition supplement in February 2009, and a second citizen petition in November 2010, requesting that FDA impose certain requirements for bioequivalence testing for ANDAs referencing FazaClo (clozapine) ODTs and modify the Clozapine Guidance (Docket Nos. FDA–2007–P–0188 and FDA–2010–P–0574). FDA is denying these petitions today. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on bioequivalence recommendations for clozapine. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. tkelley on DSK3SPTVN1PROD with NOTICES III. Electronic Access Persons with access to the Internet may obtain the documents at either https://www.fda.gov/Drugs/ GuidanceCompliance RegulatoryInformation/Guidances/ default.htm or https:// www.regulations.gov. 2 The formatting of this guidance was updated in March 2011, but the content is unchanged. The March 2011 version is available at https:// www.fda.gov/downloads/Drugs/Guidance ComplianceRegulatoryInformation/Guidances/ UCM249219.pdf. VerDate Sep<11>2014 18:43 May 05, 2015 Jkt 235001 Dated: April 30, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–10478 Filed 5–5–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Center for Scientific Review; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings. The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Selected Topics and Transfusion Medicine. Date: June 1–2, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health; 6701 Rockledge Drive; Bethesda, MD 20892; (Virtual Meeting). Contact Person: Bukhtiar H Shah, DVM, Ph.D.; Scientific Review Officer; Center for Scientific Review; National Institutes of Health; 6701 Rockledge Drive, Room 4120, MSC 7802; Bethesda, MD 20892; 301–806– 7314; shahb@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; PAR Panel: Selected Topics and Transfusion Medicine. Date: June 1–2, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: National Institutes of Health; 6701 Rockledge Drive; Bethesda, MD 20892; (Virtual Meeting). Contact Person: Katherine M Malinda, Ph.D.; Scientific Review Officer; Center for Scientific Review; National Institutes of Health; 6701 Rockledge Drive, Room 4140, MSC 7814; Bethesda, MD 20892; 301–435– 0912; Katherine_Malinda@csr.nih.gov. Name of Committee: Center for Scientific Review Special Emphasis Panel; Child Psychopathology and Developmental Disabilities. Date: June 2–3, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. PO 00000 Frm 00070 Fmt 4703 Sfmt 4703 Place: National Institutes of Health; 6701 Rockledge Drive; Bethesda, MD 20892; (Virtual Meeting). Contact Person: Jane A. DoussardRoosevelt, Ph.D.; Scientific Review Officer; Center for Scientific Review; National Institutes of Health; 6701 Rockledge Drive, Room 3184, MSC 7848; Bethesda, MD 20892; (301) 435–4445; doussarj@csr.nih.gov. Name of Committee: Brain Disorders and Clinical Neuroscience Integrated Review Group; Pathophysiological Basis of Mental Disorders and Addictions Study Section. Date: June 3–4, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: The Warwick Allerton Hotel; 701 North Michigan Avenue; Chicago, IL 60611. Contact Person: Boris P Sokolov, Ph.D.; Scientific Review Officer; Center for Scientific Review; National Institutes of Health; 6701 Rockledge Drive, Room 5217A, MSC 7846; Bethesda, MD 20892; 301–408– 9115; bsokolov@csr.nih.gov. Name of Committee: Vascular and Hematology Integrated Review Group; Molecular and Cellular Hematology Study Section. Date: June 3–4, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Embassy Suites at the Chevy Chase Pavilion; 4300 Military Road NW.; Washington, DC 20015. Contact Person: Luis Espinoza, Ph.D.; Scientific Review Officer; Center for Scientific Review; National Institutes of Health; 6701 Rockledge Drive, Room 6183, MSC 7804; Bethesda, MD 20892; 301–495– 1213; espinozala@mail.nih.gov. Name of Committee: Biobehavioral and Behavioral Processes Integrated Review Group; Cognition and Perception Study Section. Date: June 4–5, 2015. Time: 8:00 a.m. to 5:00 p.m. Agenda: To review and evaluate grant applications. Place: Historic Inns of Annapolis; 58 State Circle; Annapolis, MD 21401. Contact Person: Dana Jeffrey Plude, Ph.D.; Scientific Review Officer; Center for Scientific Review; National Institutes of Health; 6701 Rockledge Drive, Room 3176, MSC 7848; Bethesda, MD 20892; (301) 435– 2309; pluded@csr.nih.gov. Name of Committee: Biology of Development and Aging Integrated Review Group; International and Cooperative Projects—1 Study Section. Date: June 4, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Villa Florence Hotel; 225 Powell Street; San Francisco, CA 94102. Contact Person: Hilary D Sigmon, Ph.D.; Scientific Review Officer; Center for Scientific Review; National Institutes of Health; 6701 Rockledge Drive, Room 5222, MSC 7852; Bethesda, MD 20892; (301) 594– 6377; sigmonh@csr.nih.gov. Name of Committee: Risk, Prevention and Health Behavior Integrated Review Group; E:\FR\FM\06MYN1.SGM 06MYN1

Agencies

[Federal Register Volume 80, Number 87 (Wednesday, May 6, 2015)]
[Notices]
[Pages 26063-26064]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-10478]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1378]


Bioequivalence Recommendations for Clozapine Orally 
Disintegrating Tablets/Oral; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``Bioequivalence 
Recommendations for Clozapine,'' for the orally disintegrating tablets 
(ODTs). The recommendations provide specific guidance on the design of 
bioequivalence (BE) studies to support abbreviated new drug 
applications (ANDAs) for clozapine ODTs.

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 comment on the 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by July 6, 2015.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10001 New 
Hampshire Ave., Hillandale Building, 4th Floor, 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 documents.
    Submit electronic comments on the draft guidance to https://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: Xiaoqiu Tang, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-
796-5850.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 11, 2010 (75 FR 33311), FDA 
announced the availability of a guidance for industry, ``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 https://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. This notice announces the availability of one 
draft BE recommendation for clozapine ODTs.
    Clozapine tablets, marketed under the name CLOZARIL, are the 
subject of new drug application (NDA) 19-758, held by Novartis 
Pharmaceuticals Corporation and approved by FDA on September 26, 1989. 
FazaClo ODTs were approved by FDA on February 19, 2004, under NDA 21-
590, currently held by Jazz Pharmaceuticals III International LTD, 
based upon a finding that FazaClo ODTs were bioequivalent to CLOZARIL 
immediate-release tablets. FazaClo ODTs are available as yellow, orally 
disintegrating tablets of 12.5, 25, 100, 150, and 200 \1\ milligrams 
(mg) of clozapine for oral administration without water. They are 
formulated to disintegrate once exposed to saliva and then are easily 
swallowed.
---------------------------------------------------------------------------

    \1\ FDA approved the supplemental NDA for the 150 and 200 mg 
strengths on July 9, 2010.
---------------------------------------------------------------------------

    In June 2005, FDA published a guidance for industry entitled 
``Clozapine Tablets: In Vivo Bioequivalence and In Vitro Dissolution 
Testing'' (Clozapine Guidance) (70 FR 35447, June 20, 2005), which 
replaced a 1996 product-specific bioequivalence guidance for clozapine 
tablets. The 2005 Clozapine Guidance recommends that ANDA applicants 
employ multiple-dose, steady-state studies to evaluate the

[[Page 26064]]

bioequivalence of clozapine products.\2\ FDA recommends that such 
studies be performed only in patients who have not responded well to 
standard antipsychotic drug treatment and who have been receiving a 
maintenance dose of an approved clozapine product for at least 3 
months. FDA is now issuing a draft guidance for industry on BE 
recommendations for generic clozapine that applies specifically to the 
ODTs.
---------------------------------------------------------------------------

    \2\ The formatting of this guidance was updated in March 2011, 
but the content is unchanged. The March 2011 version is available at 
https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM249219.pdf.
---------------------------------------------------------------------------

    Beckloff Associates, Inc., filed a citizen petition in December 
2007, a citizen petition supplement in February 2009, and a second 
citizen petition in November 2010, requesting that FDA impose certain 
requirements for bioequivalence testing for ANDAs referencing FazaClo 
(clozapine) ODTs and modify the Clozapine Guidance (Docket Nos. FDA-
2007-P-0188 and FDA-2010-P-0574). FDA is denying these petitions today.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on bioequivalence 
recommendations for clozapine. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). 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. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the documents at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.

    Dated: April 30, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-10478 Filed 5-5-15; 8:45 am]
BILLING CODE 4164-01-P
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