81 FR 24107 - Determination That THALITONE (Chlorthalidone USP) Tablets, 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 79 (April 25, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 79 (April 25, 2016)
| Page Range | 24107-24108 | |
| FR Document | 2016-09450 |
[Federal Register Volume 81, Number 79 (Monday, April 25, 2016)] [Notices] [Pages 24107-24108] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-09450] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-P-3299] Determination That THALITONE (Chlorthalidone USP) Tablets, 15 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) has determined that THALITONE (chlorthalidone USP) tablets, 15 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for [[Page 24108]] chlorthalidone USP tablets, 15 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Christopher Koepke, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 240- 402-3543. SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ``listed drug,'' which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ``Approved Drug Products With Therapeutic Equivalence Evaluations,'' which is known generally as the ``Orange Book.'' Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale, but must be made prior to approving an ANDA that refers to the listed drug (Sec. 314.161 (21 CFR 314.161)). FDA may not approve an ANDA that does not refer to a listed drug. THALITONE (chlorthalidone USP) tablets, 15 mg, are the subject of NDA 19-574, held by Citron Pharma LLC, and initially approved on December 20, 1988. THALITONE is indicated for the management of hypertension either alone or in combination with other antihypertensive drugs. Chlorthalidone is indicated as an adjunctive therapy in edema associated with congestive heart failure, hepatic cirrhosis, and corticosteroid and estrogen therapy. Chlorthalidone has also been found useful in edema due to various forms of renal dysfunction such as nephrotic syndrome, acute glomerulonephritis, and chronic renal failure. THALITONE (chlorthalidone USP) tablets, 15 mg, are currently listed in the ``Discontinued Drug Product List'' section of the Orange Book. Clinipace Worldwide submitted a citizen petition dated September 9, 2015 (Docket No. FDA-2015-P-3299), under 21 CFR 10.30, requesting that the Agency determine whether THALITONE (chlorthalidone USP) tablets, 15 mg, were withdrawn from sale for reasons of safety or effectiveness. After considering the citizen petition and reviewing Agency records and based on the information, FDA has determined under Sec. 314.161 that THALITONE (chlorthalidone USP) tablets, 15 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that THALITONE (chlorthalidone USP) tablets, 15 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of THALITONE (chlorthalidone USP) tablets, 15 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. We have reviewed the available evidence and determined that this drug product was not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list THALITONE (chlorthalidone USP) tablets, 15 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 THALITONE (chlorthalidone USP) tablets, 15 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 this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: April 19, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-09450 Filed 4-22-16; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Notices 24107
made publicly available, you can SUPPLEMENTARY INFORMATION: II. Paperwork Reduction Act of 1995
provide this information on the cover This revised draft guidance refers to
sheet and not in the body of your I. Background
previously approved collections of
comments and you must identify this FDA is announcing the availability of information that are subject to review by
information as ‘‘confidential.’’ Any a revised draft guidance for industry the Office of Management and Budget
information marked as ‘‘confidential’’ entitled ‘‘Assay Development and (OMB) under the Paperwork Reduction
will not be disclosed except in Validation for Immunogenicity Testing Act of 1995 (44 U.S.C. 3501–3520). The
accordance with 21 CFR 10.20 and other of Therapeutic Protein Products.’’ collections of information in 21 CFR
applicable disclosure law. For more Patient immune responses to part 312 have been approved under
information about FDA’s posting of therapeutic protein products have the OMB control number 0910–0014; the
comments to public dockets, see 80 FR potential to affect product safety and collections of information in 21 CFR
56469, September 18, 2015, or access part 314 have been approved under
efficacy. The clinical effects of patient
the information at: http://www.fda.gov/ OMB control numbers 0910–0001 and
immune responses are highly variable,
regulatoryinformation/dockets/ 0910–0230; the collections of
ranging from no effect at all to extreme
default.htm. information in 21 CFR part 58 have been
Docket: For access to the docket to harmful effects to patient health.
Detection and analysis of ADA approved under OMB control number
read background documents or the 0910–0119; and the collections of
electronic and written/paper comments formation is a helpful tool in
understanding potential patient immune information in 21 CFR part 601 have
received, go to http:// been approved under OMB control
www.regulations.gov and insert the responses. Information on immune
responses observed during clinical numbers 0910–0338 and 0910–0719.
docket number, found in brackets in the
heading of this document, into the trials, particularly the incidence of ADA III. Electronic Access
‘‘Search’’ box and follow the prompts induction and the implications of ADA
Persons with access to the Internet
and/or go to the Division of Dockets responses for drug safety and efficacy, is
may obtain the document at http://
Management, 5630 Fishers Lane, Rm. crucial for any therapeutic product
www.fda.gov/Drugs/
1061, Rockville, MD 20852. development program. Accordingly,
GuidanceCompliance
Submit written requests for single such information, if applicable, should
RegulatoryInformation/Guidances/
copies of the revised draft guidance to be included in the prescribing
default.htm, or http://www.fda.gov/
the Division of Drug Information, Center information as a subsection of the BiologicsBloodVaccines/
for Drug Evaluation and Research, Food ADVERSE REACTIONS section entitled GuidanceCompliance
and Drug Administration, 10001 New ‘‘Immunogenicity.’’ RegulatoryInformation/Guidances/
Hampshire Ave., Hillandale Building, In general, assays for detection of default.htm, or http://www.fda.gov/
4th Floor, Silver Spring, MD 20993– ADA facilitate understanding of the MedicalDevices/DeviceRegulationand
0002; or the Office of Communication, immunogenicity, safety, and efficacy of Guidance/GuidanceDocuments/
Outreach, and Development, Center for therapeutic protein products. However, default.htm, or http://
Biologics Evaluation and Research, the detection of ADA is dependent on www.regulations.gov.
Food and Drug Administration, 10903 key operating parameters of the assays
New Hampshire Ave., Bldg. 71, Rm. Dated: April 19, 2016.
(e.g., sensitivity, specificity), which vary Leslie Kux,
3128, Silver Spring, MD 20993–0002; or between assays. Therefore, the
the Office of the Center Director, Associate Commissioner for Policy.
development of valid, sensitive,
Guidance and Policy Development, [FR Doc. 2016–09449 Filed 4–22–16; 8:45 am]
specific, and selective assays to measure
Center for Devices and Radiological BILLING CODE 4164–01–P
ADA responses is a key aspect of
Health, Food and Drug Administration,
therapeutic protein product
10903 New Hampshire Ave., Bldg. 66,
development. DEPARTMENT OF HEALTH AND
Rm. 5431, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive This guidance revises the draft HUMAN SERVICES
label to assist that office in processing guidance for industry entitled ‘‘Assay
your requests. See the SUPPLEMENTARY Development for Immunogenicity Food and Drug Administration
INFORMATION section for electronic Testing of Therapeutic Proteins’’ issued [Docket No. FDA–2015–P–3299]
access to the revised draft guidance in December 2009. The information in
document. the draft guidance has been reorganized Determination That THALITONE
for clarity, and the revised draft (Chlorthalidone USP) Tablets, 15
FOR FURTHER INFORMATION CONTACT: Ebla
guidance includes new information on Milligrams, Were Not Withdrawn From
Ali Ibrahim, Center for Drug Evaluation
titering and confirmatory assays. Sale for Reasons of Safety or
and Research, Food and Drug
Administration, 10903 New Hampshire This revised draft guidance is being Effectiveness
Ave., Bldg. 51, Rm. 6308, Silver Spring, issued consistent with FDA’s good AGENCY: Food and Drug Administration,
MD 20993, 301–796–0281; or Stephen guidance practices regulation (21 CFR HHS.
Ripley, Center for Biologics Evaluation 10.115). The revised draft guidance, ACTION: Notice.
and Research, Food and Drug when finalized, will represent the
Administration, 10903 New Hampshire current thinking of FDA on assay SUMMARY: The Food and Drug
asabaliauskas on DSK3SPTVN1PROD with NOTICES
Ave., Bldg. 71, Rm. 7301, Silver Spring, development and validation for Administration (FDA or Agency) has
MD 20993–0002, 240–402–7911; or immunogenicity testing of therapeutic determined that THALITONE
Peter Hudson, Center for Devices and protein products. It does not establish (chlorthalidone USP) tablets, 15
Radiological Health, Food and Drug any rights for any person and is not milligrams (mg), were not withdrawn
Administration, 10903 New Hampshire binding on FDA or the public. You can from sale for reasons of safety or
Ave., Bldg. 66, Rm. G434 (HFZ–410), use an alternative approach if it satisfies effectiveness. This determination will
Silver Spring, MD, 20993–0002, 301– the requirements of the applicable allow FDA to approve abbreviated new
796–6440. statutes and regulations. drug applications (ANDAs) for
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![24108 Federal Register / Vol. 81, No. 79 / Monday, April 25, 2016 / Notices
chlorthalidone USP tablets, 15 mg, if all failure, hepatic cirrhosis, and DEPARTMENT OF HEALTH AND
other legal and regulatory requirements corticosteroid and estrogen therapy. HUMAN SERVICES
are met. Chlorthalidone has also been found
FOR FURTHER INFORMATION CONTACT: useful in edema due to various forms of Indian Health Service
Christopher Koepke, Center for Drug renal dysfunction such as nephrotic
syndrome, acute glomerulonephritis, Request for Public Comment: 60-Day
Evaluation and Research, Food and
and chronic renal failure. Information Collection: Indian Self-
Drug Administration, 10903 New
THALITONE (chlorthalidone USP) Determination and Education
Hampshire Ave., Bldg. 51, Rm. 6214,
tablets, 15 mg, are currently listed in the Assistance Act Contracts
Silver Spring, MD 20993–0002, 240–
402–3543. ‘‘Discontinued Drug Product List’’
section of the Orange Book. AGENCY: Indian Health Service, HHS.
SUPPLEMENTARY INFORMATION: In 1984,
Clinipace Worldwide submitted a ACTION:Notice and request for
Congress enacted the Drug Price citizen petition dated September 9, 2015 comments. Request for extension of
Competition and Patent Term (Docket No. FDA–2015–P–3299), under approval.
Restoration Act of 1984 (Pub. L. 98–417) 21 CFR 10.30, requesting that the
(the 1984 amendments), which Agency determine whether SUMMARY: In compliance the Paperwork
authorized the approval of duplicate THALITONE (chlorthalidone USP) Reduction Act of 1995, the Indian
versions of drug products under an tablets, 15 mg, were withdrawn from Health Service (IHS) invites the general
ANDA procedure. ANDA applicants sale for reasons of safety or public to comment on the information
must, with certain exceptions, show that effectiveness. collection titled, ‘‘Indian Self-
the drug for which they are seeking After considering the citizen petition Determination and Education
approval contains the same active and reviewing Agency records and Assistance Act Contracts,’’ Office of
ingredient in the same strength and based on the information, FDA has Management and Budget (OMB) Control
dosage form as the ‘‘listed drug,’’ which determined under § 314.161 that Number 0917–0037. IHS is requesting
is a version of the drug that was THALITONE (chlorthalidone USP) OMB to approve an extension for this
previously approved. ANDA applicants tablets, 15 mg, were not withdrawn for collection, which expires on July 31,
do not have to repeat the extensive reasons of safety or effectiveness. The 2016.
clinical testing otherwise necessary to petitioner has identified no data or other
gain approval of a new drug application DATES: Comment Due Date: June 24,
information suggesting that
(NDA). 2016. Your comments regarding this
THALITONE (chlorthalidone USP)
The 1984 amendments include what information collection are best assured
tablets, 15 mg, were withdrawn for
is now section 505(j)(7) of the Federal of having full effect if received within
reasons of safety or effectiveness. We
Food, Drug, and Cosmetic Act (21 U.S.C. 60 days of the date of this publication.
have carefully reviewed our files for
355(j)(7)), which requires FDA to records concerning the withdrawal of ADDRESSES: Send your written
publish a list of all approved drugs. THALITONE (chlorthalidone USP) comments, requests for more
FDA publishes this list as part of the tablets, 15 mg, from sale. We have also information on the collection, or
‘‘Approved Drug Products With independently evaluated relevant requests to obtain a copy of the data
Therapeutic Equivalence Evaluations,’’ literature and data for possible collection instrument and instructions
which is known generally as the postmarketing adverse events. We have to Mr. Chris Buchanan by one of the
‘‘Orange Book.’’ Under FDA regulations, reviewed the available evidence and following methods:
drugs are removed from the list if the determined that this drug product was • Mail: Mr. Chris Buchanan, Director,
Agency withdraws or suspends not withdrawn from sale for reasons of IHS Office of Direct Services and
approval of the drug’s NDA or ANDA safety or effectiveness. Contracting Tribes (ODSCT), Indian
for reasons of safety or effectiveness or Accordingly, the Agency will Health Service, 5600 Fishers Lane, Mail
if FDA determines that the listed drug continue to list THALITONE Stop O8E17C, Rockville, MD 20857.
was withdrawn from sale for reasons of (chlorthalidone USP) tablets, 15 mg, in • Phone: 301–443–1104.
safety or effectiveness (21 CFR 314.162). the ‘‘Discontinued Drug Product List’’ • Email: Chris.Buchanan@ihs.gov.
A person may petition the Agency to section of the Orange Book. The
determine, or the Agency may • Fax: 301–480–3192.
‘‘Discontinued Drug Product List’’
determine on its own initiative, whether delineates, among other items, drug SUPPLEMENTARY INFORMATION: This
a listed drug was withdrawn from sale products that have been discontinued previously approved information
for reasons of safety or effectiveness. from marketing for reasons other than collection project was last published in
This determination may be made at any safety or effectiveness. ANDAs that refer the Federal Register (78 FR 32405), as
time after the drug has been withdrawn to THALITONE (chlorthalidone USP) a joint submission with the Bureau of
from sale, but must be made prior to tablets, 15 mg, may be approved by the Indian Affairs (BIA), under OMB
approving an ANDA that refers to the Agency as long as they meet all other Control Number 1076–0136, on May 30,
listed drug (§ 314.161 (21 CFR 314.161)). legal and regulatory requirements for 2013 and allowed 30 days for public
FDA may not approve an ANDA that the approval of ANDAs. If FDA comment. No public comment was
does not refer to a listed drug. determines that labeling for this drug received in response to the notice. On
THALITONE (chlorthalidone USP) product should be revised to meet July 31, 2013, the IHS obtained its own
tablets, 15 mg, are the subject of NDA OMB Control Number, 0917–0037, for
asabaliauskas on DSK3SPTVN1PROD with NOTICES
current standards, the Agency will
19–574, held by Citron Pharma LLC, advise ANDA applicants to submit such this information collection and is now
and initially approved on December 20, labeling. publishing a separate notice from the
1988. THALITONE is indicated for the BIA in the Federal Register. The
management of hypertension either Dated: April 19, 2016. purpose of this notice is to allow 60
alone or in combination with other Leslie Kux, days for public comment. A copy of the
antihypertensive drugs. Chlorthalidone Associate Commissioner for Policy. supporting statement is available at
is indicated as an adjunctive therapy in [FR Doc. 2016–09450 Filed 4–22–16; 8:45 am] www.regulations.gov (see Docket ID
edema associated with congestive heart BILLING CODE 4164–01–P IHS–2016–0003).
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Document Created: 2016-04-23 01:38:29
Document Modified: 2016-04-23 01:38:29
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | Christopher Koepke, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6214, Silver Spring, MD 20993-0002, 240- 402-3543. | |
| FR Citation | 81 FR 24107 |
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