Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability, 66743-66744 [2013-26570]

Download as PDF Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Notices (5 mg, 10 mg, and 25 mg) were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of MOBAN (molindone HCl) tablets (5 mg, 10 mg, 25 mg, 50 mg, and 100 mg) and capsules (5 mg, 10 mg, and 25 mg) from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that these products were withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list MOBAN (molindone HCl) tablets (5 mg, 10 mg, 25 mg, 50 mg, and 100 mg) and capsules (5 mg, 10 mg, and 25 mg) in the ‘‘Discontinued Drug Product List’’ section of the Orange Book. The ‘‘Discontinued Drug Product List’’ delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. ANDAs that refer to MOBAN (molindone HCl) tablets (5 mg, 10 mg, 25 mg, 50 mg, and 100 mg) or capsules (5 mg, 10 mg, and 25 mg) may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: October 31, 2013. Leslie Kux, Assistant Commissioner for Policy. BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2007–D–0369] Draft Guidance for Industry on Bioequivalence Recommendations for Iron Sucrose; Availability Food and Drug Administration, HHS.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 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Bioequivalence Recommendations for Iron Sucrose.’’ The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:25 Nov 05, 2013 Jkt 232001 Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 2201,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 document. Submit electronic comments on the draft guidance 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: Kris Andre, Center for Drug Evaluation and Research (HFD–600), Food and Drug Administration, 7520 Standish Pl., Rockville, MD 20855, 240–276–8866. SUPPLEMENTARY INFORMATION: ADDRESSES: I. Background [FR Doc. 2013–26550 Filed 11–5–13; 8:45 am] AGENCY: (ANDAs) for iron sucrose injection. The draft guidance is a revised version of a previously issued draft guidance on the same subject. 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 this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by January 6, 2014. 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 productspecific BE recommendations available to the public on FDA’s Web site at http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ 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 draft BE recommendations for iron sucrose injection (Draft Iron Sucrose Injection BE Recommendations of 2013). Venofer (iron sucrose injection), new drug application 021135, was initially approved by FDA in November 2000. There are no approved ANDAs for this product. PO 00000 Frm 00063 Fmt 4703 Sfmt 4703 66743 In March 2012, FDA posted on its Web site a draft guidance for industry on the Agency’s recommendations for BE studies to support ANDAs for iron sucrose injection (Draft Iron Sucrose Injection BE Recommendations of 2012). In that draft guidance, FDA recommended an in vivo fasting BE study with pharmacokinetic endpoints and in vitro studies. FDA has reconsidered the recommendations in the Draft Iron Sucrose Injection BE Recommendations of 2012 and has decided to revise it. At this time, FDA is withdrawing the Draft Iron Sucrose Injection BE Recommendations of 2012 and is issuing a revised draft guidance for industry, the Draft Iron Sucrose Injection BE Recommendations of 2013. In this revised draft guidance, FDA recommends that for the in vivo pharmacokinetic study the difference between total iron and transferrinbound iron be used to demonstrate BE of generic iron sucrose injection products. FDA is no longer recommending baseline-adjusted total iron and baseline-adjusted transferrinbound iron be used to demonstrate BE of generic iron sucrose injection products. The revised draft guidance also provides updated information about the recommended studies for in vitro characterization and criteria for waiver of in vivo testing. In March 2005, Luitpold Pharmaceuticals, Inc. (Luitpold), manufacturer of the reference listed drug, Venofer, submitted (through its attorneys) a citizen petition requesting that FDA withhold approval of any ANDA or 505(b)(2) application for a generic iron sucrose injection unless certain conditions were satisfied, including conditions related to demonstrating BE (Docket No. FDA– 2005–P–0319, formerly 2005P–0095/ CP1). FDA is reviewing the issues raised in the petition and is also reviewing the supplemental information and comments that have been submitted to the docket for that petition. FDA will consider any comments on the Draft Iron Sucrose Injection BE Recommendations of 2013 before responding to Luitpold’s citizen petition. 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 Agency’s current thinking on the design of BE studies to support ANDAs for iron sucrose injection. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the E:\FR\FM\06NON1.SGM 06NON1 66744 Federal Register / Vol. 78, No. 215 / Wednesday, November 6, 2013 / Notices requirements of the applicable statutes and regulations. II. Comments Interested persons may submit either electronic comments regarding this document to http://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 http:// www.regulations.gov. III. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. Dated: October 31, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–26570 Filed 11–5–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–D–1319] Draft Guidance for Industry on Pulmonary Tuberculosis: Developing Drugs for Treatment; 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 ‘‘Pulmonary Tuberculosis: Developing Drugs for Treatment.’’ The purpose of the draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of pulmonary tuberculosis. This guidance applies to the development of a single investigational drug as well as development of two or more unmarketed investigational drugs for use in combination. 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 this draft guidance before it begins work on the final version of the guidance, submit mstockstill on DSK4VPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:25 Nov 05, 2013 Jkt 232001 either electronic or written comments on the draft guidance by February 4, 2014. 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, 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 document. Submit electronic comments on the draft guidance 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: Eileen Navarro, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6126, Silver Spring, MD 20993–0002, 301– 796–1300; or Joseph G. Toerner, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993–0002, 301– 796–1300. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Pulmonary Tuberculosis: Developing Drugs for Treatment.’’ The purpose of this draft guidance is to assist sponsors in the development of antimycobacterial drugs for the treatment of pulmonary tuberculosis. Tuberculosis remains endemic in the United States and is epidemic in many parts of the world. Current treatment for tuberculosis involves administration of multiple-drug regimens for a minimum of 6 months. The development of new drugs for treatment of pulmonary tuberculosis remains an important public health goal. Some of the public health challenges to be addressed in the treatment of tuberculosis include: (1) The administration of new drug regimens for shorter periods of time; (2) new drugs that do not have drug-drug interactions with the drugs used to treat human immunodeficiency virus/ acquired immunodeficiency syndrome; and (3) new drugs that are active in the treatment of patients with drug-resistant tuberculosis. This draft guidance addresses these issues in the context of clinical trial designs for new drugs. The draft guidance addresses the PO 00000 Frm 00064 Fmt 4703 Sfmt 4703 complexities of the superiority clinical trial design, where an investigational drug is found to be superior on a clinical endpoint while ensuring that all patients in trials receive appropriately active treatment regimens. The draft guidance includes a discussion of noninferiority clinical trial designs, with justification for a noninferiority margin in the setting of treatmentshortening regimens. The draft guidance also discusses clinical trials designed to include patients with drug-resistant tuberculosis. 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 Agency’s current thinking on ‘‘Pulmonary Tuberculosis: Developing Drugs for Treatment.’’ It does not create or confer any rights for or on any person and does 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. II. The Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information that 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 312 and 21 CFR part 314 have been approved under OMB control numbers 0910–0014 and 0910–0001, respectively. III. Comments Interested persons may submit either electronic comments regarding this document to http://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 http:// www.regulations.gov. IV. Electronic Access Persons with access to the Internet may obtain the document at either http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or http:// www.regulations.gov. E:\FR\FM\06NON1.SGM 06NON1

Agencies

[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Pages 66743-66744]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-26570]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0369]


Draft Guidance for Industry on Bioequivalence Recommendations for 
Iron Sucrose; 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 Iron Sucrose.'' The recommendations provide 
specific guidance on the design of bioequivalence (BE) studies to 
support abbreviated new drug applications (ANDAs) for iron sucrose 
injection. The draft guidance is a revised version of a previously 
issued draft guidance on the same subject.

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 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by January 6, 2014.

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, 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 document.
    Submit electronic comments on the draft guidance 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: Kris Andre, Center for Drug Evaluation 
and Research (HFD-600), Food and Drug Administration, 7520 Standish 
Pl., Rockville, MD 20855, 240-276-8866.

SUPPLEMENTARY INFORMATION: 

I. Background

    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. This notice announces the 
availability of draft BE recommendations for iron sucrose injection 
(Draft Iron Sucrose Injection BE Recommendations of 2013).
    Venofer (iron sucrose injection), new drug application 021135, was 
initially approved by FDA in November 2000. There are no approved ANDAs 
for this product.
    In March 2012, FDA posted on its Web site a draft guidance for 
industry on the Agency's recommendations for BE studies to support 
ANDAs for iron sucrose injection (Draft Iron Sucrose Injection BE 
Recommendations of 2012). In that draft guidance, FDA recommended an in 
vivo fasting BE study with pharmacokinetic endpoints and in vitro 
studies. FDA has reconsidered the recommendations in the Draft Iron 
Sucrose Injection BE Recommendations of 2012 and has decided to revise 
it. At this time, FDA is withdrawing the Draft Iron Sucrose Injection 
BE Recommendations of 2012 and is issuing a revised draft guidance for 
industry, the Draft Iron Sucrose Injection BE Recommendations of 2013. 
In this revised draft guidance, FDA recommends that for the in vivo 
pharmacokinetic study the difference between total iron and 
transferrin-bound iron be used to demonstrate BE of generic iron 
sucrose injection products. FDA is no longer recommending baseline-
adjusted total iron and baseline-adjusted transferrin-bound iron be 
used to demonstrate BE of generic iron sucrose injection products. The 
revised draft guidance also provides updated information about the 
recommended studies for in vitro characterization and criteria for 
waiver of in vivo testing.
    In March 2005, Luitpold Pharmaceuticals, Inc. (Luitpold), 
manufacturer of the reference listed drug, Venofer, submitted (through 
its attorneys) a citizen petition requesting that FDA withhold approval 
of any ANDA or 505(b)(2) application for a generic iron sucrose 
injection unless certain conditions were satisfied, including 
conditions related to demonstrating BE (Docket No. FDA-2005-P-0319, 
formerly 2005P-0095/CP1). FDA is reviewing the issues raised in the 
petition and is also reviewing the supplemental information and 
comments that have been submitted to the docket for that petition. FDA 
will consider any comments on the Draft Iron Sucrose Injection BE 
Recommendations of 2013 before responding to Luitpold's citizen 
petition.
    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 Agency's current thinking on the design 
of BE studies to support ANDAs for iron sucrose injection. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the

[[Page 66744]]

requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://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 http://www.regulations.gov.

III. 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: October 31, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-26570 Filed 11-5-13; 8:45 am]
BILLING CODE 4160-01-P