83 FR 7046 - Determination That LOTENSIN HCT (Benazepril Hydrochloride; Hydrochlorothiazide) Oral Tablets, 5 Milligrams and 6.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness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 83, Issue 33 (February 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 33 (February 16, 2018)
| Page Range | 7046-7047 | |
| FR Document | 2018-03188 |
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)] [Notices] [Pages 7046-7047] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03188] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-P-4852] Determination That LOTENSIN HCT (Benazepril Hydrochloride; Hydrochlorothiazide) Oral Tablets, 5 Milligrams and 6.25 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS.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that LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 milligrams (mg) and 6.25 mg, were not withdrawn from sale for reasons of safety or effectiveness.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 benazepril hydrochloride; hydrochlorothiazide oral tablets, 5 mg and 6.25 mg, if all other legal and regulatory requirements are met. FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, [email protected]. 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 [[Page 7047]] 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. LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, are the subject of NDA 020033, held by U.S. Pharmaceutical Holdings I, LLC, and initially approved on May 19, 1992. LOTENSIN HCT is indicated for the relief of symptoms of depression. LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, are currently listed in the ``Discontinued Drug Product List'' section of the Orange Book. EAS Consulting Group, LLC submitted a citizen petition dated August 9, 2017 (Docket No. FDA-2017-P-4852), under 21 CFR 10.30, requesting that the Agency determine whether LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 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 we have at this time, FDA has determined under Sec. 314.161 that LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, were not withdrawn for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that these products were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, from sale. We have also independently evaluated relevant literature and data for possible post-marketing adverse events. We have found no information that would indicate that this drug product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 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 LOTENSIN HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 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 this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling. Dated: February 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03188 Filed 2-15-18; 8:45 am] BILLING CODE 4164-01-P
![7046 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
additional work. The applicant would dataset for each application would take assurance procedures, which would add
likely perform more quality assurance, approximately 40 hours to prepare. approximately 2 hours for each
which may add time to preparation and Initial preparation of the clinical study- submission.
review of the submission. level information, subject-level data line This draft guidance also refers to
Based on CDER’s data on the number listings by clinical site, and the previously approved collections of
of NDAs, BLAs, and NDA and BLA summary-level clinical site dataset information found in FDA regulations.
supplemental applications containing could involve the development of new The collections of information in part
new clinical study reports that would be SOPs for some applicants. We estimate
covered by the draft guidance, we 312 have been approved under OMB
that 75 applicants would take control number 0910–0014; the
estimate that each year approximately
approximately 20 hours to develop and collections of information in part 314
75 applicants will submit for 125
original NDA or BLA applications and subsequently 2 hours annually to have been approved under OMB control
152 supplemental applications maintain and update the SOP(s). The number 0910–0001; the collections of
containing new clinical study reports. clinical study-level information, subject- information in part 601 have been
We estimate that the submission of the level data line listings by clinical site, approved under OMB control number
clinical study-level information, subject- and the summary-level clinical site 0910–0338.
level data line listings by clinical site, dataset submitted with each application FDA estimates the burden of this
and the summary-level clinical site would likely involve additional quality collection of information as follows:
TABLE 1—ESTIMATED REPORTING BURDEN 1
Number of
Number of responses per Total Hours per
Activity respondents Total hours
respondent responses response
(i.e., applicants) (i.e., applications)
Submissions (clinical study-level information,
subject-level data line listings by clinical
site, and the summary-level clinical site
dataset) ......................................................... 75 3.7 277 40 11,080
Quality Assurance ............................................ 75 3.7 277 2 554
Total .......................................................... ................................ .................................... ........................ ........................ 11,634
1 There are no capital costs or operating and maintenance costs associated with this information collection.
TABLE 2—ESTIMATED RECORDKEEPING BURDEN 1
Number of
Number of Total Hours per
Activity records per Total hours
recordkeepers records recordkeeper
recordkeeper
Develop Initial SOP(s) ......................................................... 75 1 75 20 1,500
Maintain and Update SOP(s) ............................................... 75 1 75 2 150
Total .............................................................................. ........................ ........................ ........................ ........................ 1,650
1 There are no capital costs or operating and maintenance costs associated with this information collection.
II. Electronic Access DEPARTMENT OF HEALTH AND withdrawn from sale for reasons of
HUMAN SERVICES safety or effectiveness. This
Persons with access to the internet determination will allow FDA to
may obtain the draft guidance at either Food and Drug Administration approve abbreviated new drug
https://www.fda.gov/Drugs/Guidance applications (ANDAs) for benazepril
[Docket No. FDA–2017–P–4852]
ComplianceRegulatoryInformation/ hydrochloride; hydrochlorothiazide oral
Guidances/default.htm or https:// Determination That LOTENSIN HCT tablets, 5 mg and 6.25 mg, if all other
www.regulations.gov. (Benazepril Hydrochloride; legal and regulatory requirements are
Dated: February 9, 2018. Hydrochlorothiazide) Oral Tablets, 5 met.
Leslie Kux, Milligrams and 6.25 Milligrams, Were FOR FURTHER INFORMATION CONTACT:
Not Withdrawn From Sale for Reasons Stacy Kane, Center for Drug Evaluation
Associate Commissioner for Policy.
of Safety or Effectiveness and Research, Food and Drug
[FR Doc. 2018–03236 Filed 2–15–18; 8:45 am]
AGENCY: Food and Drug Administration, Administration, 10903 New Hampshire
BILLING CODE 4164–01–P
HHS. Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
ACTION: Notice.
daltland on DSKBBV9HB2PROD with NOTICES
Stacy.Kane@fda.hhs.gov.
SUMMARY: The Food and Drug SUPPLEMENTARY INFORMATION: In 1984,
Administration (FDA or Agency) has Congress enacted the Drug Price
determined that LOTENSIN HCT Competition and Patent Term
(benazepril hydrochloride; Restoration Act of 1984 (Pub. L. 98–417)
hydrochlorothiazide) oral tablets, 5 (the 1984 amendments), which
milligrams (mg) and 6.25 mg, were not authorized the approval of duplicate
VerDate Sep<11>2014 19:24 Feb 15, 2018 Jkt 244001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1](https://thefederalregister.org/doc/83_FR_7079/page/1.svg)
![Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices 7047
versions of drug products under an time, FDA has determined under announcing the availability of a draft
ANDA procedure. ANDA applicants § 314.161 that LOTENSIN HCT guidance for industry entitled
must, with certain exceptions, show that (benazepril hydrochloride; ‘‘Amyotrophic Lateral Sclerosis:
the drug for which they are seeking hydrochlorothiazide) oral tablets, 5 mg Developing Drugs for Treatment.’’ The
approval contains the same active and 6.25 mg, were not withdrawn for purpose of this guidance is to assist
ingredient in the same strength and reasons of safety or effectiveness. The sponsors in the clinical development of
dosage form as the ‘‘listed drug,’’ which petitioner has identified no data or other drugs for the treatment of amyotrophic
is a version of the drug that was information suggesting that these lateral sclerosis (ALS). Specifically, it
previously approved. ANDA applicants products were withdrawn for reasons of addresses FDA’s current thinking
do not have to repeat the extensive safety or effectiveness. We have regarding the clinical development
clinical testing otherwise necessary to carefully reviewed our files for records program and clinical trial designs for
gain approval of a new drug application concerning the withdrawal of drugs to support an indication for the
(NDA). LOTENSIN HCT (benazepril treatment of ALS. This guidance
The 1984 amendments include what hydrochloride; hydrochlorothiazide) addresses the clinical development of
is now section 505(j)(7) of the Federal oral tablets, 5 mg and 6.25 mg, from drugs intended to treat the main
Food, Drug, and Cosmetic Act (21 U.S.C. sale. We have also independently neuromuscular aspects of ALS (i.e.,
355(j)(7)), which requires FDA to evaluated relevant literature and data muscle weakness and its direct
publish a list of all approved drugs. for possible post-marketing adverse consequences, including shortened
FDA publishes this list as part of the events. We have found no information survival).
‘‘Approved Drug Products With that would indicate that this drug
Therapeutic Equivalence Evaluations,’’ DATES: Submit either electronic or
product was withdrawn from sale for written comments on the draft guidance
which is known generally as the reasons of safety or effectiveness.
‘‘Orange Book.’’ Under FDA regulations, by April 17, 2018 to ensure that the
Accordingly, the Agency will Agency considers your comment on this
drugs are removed from the list if the continue to list LOTENSIN HCT
Agency withdraws or suspends draft guidance before it begins work on
(benazepril hydrochloride; the final version of the guidance.
approval of the drug’s NDA or ANDA hydrochlorothiazide) oral tablets, 5 mg
for reasons of safety or effectiveness or ADDRESSES: You may submit comments
and 6.25 mg, in the ‘‘Discontinued Drug
if FDA determines that the listed drug on any guidance at any time as follows:
Product List’’ section of the Orange
was withdrawn from sale for reasons of Book. The ‘‘Discontinued Drug Product Electronic Submissions
safety or effectiveness (21 CFR 314.162). List’’ delineates, among other items,
A person may petition the Agency to Submit electronic comments in the
drug products that have been following way:
determine, or the Agency may discontinued from marketing for reasons
determine on its own initiative, whether • Federal eRulemaking Portal:
other than safety or effectiveness. https://www.regulations.gov. Follow the
a listed drug was withdrawn from sale
ANDAs that refer to LOTENSIN HCT instructions for submitting comments.
for reasons of safety or effectiveness.
(benazepril hydrochloride; Comments submitted electronically,
This determination may be made at any
hydrochlorothiazide) oral tablets, 5 mg including attachments, to https://
time after the drug has been withdrawn
and 6.25 mg, may be approved by the www.regulations.gov will be posted to
from sale, but must be made prior to
Agency as long as they meet all other the docket unchanged. Because your
approving an ANDA that refers to the
legal and regulatory requirements for comment will be made public, you are
listed drug (§ 314.161 (21 CFR 314.161)).
the approval of ANDAs. If FDA solely responsible for ensuring that your
FDA may not approve an ANDA that
determines that labeling for this drug comment does not include any
does not refer to a listed drug.
LOTENSIN HCT (benazepril product should be revised to meet confidential information that you or a
hydrochloride; hydrochlorothiazide) current standards, the Agency will third party may not wish to be posted,
oral tablets, 5 mg and 6.25 mg, are the advise ANDA applicants to submit such such as medical information, your or
subject of NDA 020033, held by U.S. labeling. anyone else’s Social Security number, or
Pharmaceutical Holdings I, LLC, and Dated: February 9, 2018. confidential business information, such
initially approved on May 19, 1992. Leslie Kux, as a manufacturing process. Please note
LOTENSIN HCT is indicated for the Associate Commissioner for Policy. that if you include your name, contact
relief of symptoms of depression. [FR Doc. 2018–03188 Filed 2–15–18; 8:45 am] information, or other information that
LOTENSIN HCT (benazepril BILLING CODE 4164–01–P
identifies you in the body of your
hydrochloride; hydrochlorothiazide) comments, that information will be
oral tablets, 5 mg and 6.25 mg, are posted on https://www.regulations.gov.
currently listed in the ‘‘Discontinued DEPARTMENT OF HEALTH AND • If you want to submit a comment
Drug Product List’’ section of the Orange HUMAN SERVICES with confidential information that you
Book. do not wish to be made available to the
EAS Consulting Group, LLC Food and Drug Administration public, submit the comment as a
submitted a citizen petition dated written/paper submission and in the
[Docket No. FDA–2013–N–0035]
August 9, 2017 (Docket No. FDA–2017– manner detailed (see ‘‘Written/Paper
P–4852), under 21 CFR 10.30, Amyotrophic Lateral Sclerosis: Submissions’’ and ‘‘Instructions’’).
requesting that the Agency determine Developing Drugs for Treatment; Draft
whether LOTENSIN HCT (benazepril Written/Paper Submissions
daltland on DSKBBV9HB2PROD with NOTICES
Guidance for Industry; Availability
hydrochloride; hydrochlorothiazide) Submit written/paper submissions as
oral tablets, 5 mg and 6.25 mg, were AGENCY: Food and Drug Administration, follows:
withdrawn from sale for reasons of HHS. • Mail/Hand delivery/Courier (for
safety or effectiveness. ACTION: Notice of availability. written/paper submissions): Dockets
After considering the citizen petition Management Staff (HFA–305), Food and
and reviewing Agency records and SUMMARY: The Food and Drug Drug Administration, 5630 Fishers
based on the information we have at this Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852.
VerDate Sep<11>2014 19:24 Feb 15, 2018 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\16FEN1.SGM 16FEN1](https://thefederalregister.org/doc/83_FR_7079/page/2.svg)
Document Created: 2018-02-16 00:55:43
Document Modified: 2018-02-16 00:55:43
| 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 | Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, [email protected] | |
| FR Citation | 83 FR 7046 |
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