Determination That BELVIQ (Lorcaserin Hydrochloride) Tablets, 10 Milligrams, and BELVIQ XR (Lorcaserin Hydrochloride) Extended-Release Tablets, 20 Milligrams, Were Withdrawn From Sale for Reasons of Safety or Effectiveness, 12697-12698 [2021-04449]
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Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices
nominee is aware of the nomination
unless self-nominated. FDA will
forward all nominations to the
organizations expressing interest in
participating in the selection process for
the committee. (Persons who nominate
themselves as nonvoting industry
representatives will not participate in
the selection process.)
FDA seeks to include the views of
women and men, members of all racial
and ethnic groups, and individuals with
and without disabilities on its advisory
committees and, therefore, encourages
nominations of appropriately qualified
candidates from these groups.
Specifically, nominations for nonvoting
representatives of industry interests are
encouraged from the device
manufacturing industry.
This notice is issued under the
Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14,
relating to advisory committees.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04450 Filed 3–3–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0030]
Determination That BELVIQ
(Lorcaserin Hydrochloride) Tablets, 10
Milligrams, and BELVIQ XR (Lorcaserin
Hydrochloride) Extended-Release
Tablets, 20 Milligrams, Were
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that BELVIQ (lorcaserin
hydrochloride) tablets, 10 milligrams
(mg), and BELVIQ XR (lorcaserin
hydrochloride) extended-release tablets,
20 mg, were withdrawn from sale for
reasons of safety or effectiveness. The
Agency will not accept or approve
abbreviated new drug applications
(ANDAs) for lorcaserin hydrochloride
tablets, 10 mg and 20 mg.
FOR FURTHER INFORMATION CONTACT:
Sungjoon Chi, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6216,
Silver Spring, MD 20993–0002, 240–
402–9674, Sungjoon.Chi@fda.hhs.gov.
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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20:27 Mar 03, 2021
Jkt 253001
Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to seek approval to market a
generic version of a previously
approved drug product. In general, to
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product has the same
active ingredient(s); dosage form; route
of administration; strength; conditions
of use; and, with certain exceptions,
labeling as the listed drug. In addition,
the ANDA applicant must show that the
generic drug product is bioequivalent to
the listed drug.
Section 505(j)(7) of the FD&C Act
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 new
drug application (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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
BELVIQ (lorcaserin hydrochloride)
tablets, 10 mg, is the subject of NDA
022529, and BELVIQ XR (lorcaserin
hydrochloride) extended-release tablets,
20 mg, is the subject of NDA 208524,
both held by Eisai Inc. (Eisai), and
initially approved on June 27, 2012, and
July 15, 2016, respectively. BELVIQ and
BELVIQ XR are indicated as an adjunct
to a reduced-calorie diet and increased
physical activity for chronic weight
management in adults with an initial
body mass index of:
• 30 kilograms per square meter (kg/
m2) or greater (obese); or
• 27 kg/m2 or greater (overweight) in
the presence of at least one weightrelated comorbid condition (e.g.,
hypertension, dyslipidemia, type 2
diabetes).
After reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that BELVIQ (lorcaserin
hydrochloride) tablets, 10 mg, and
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00105
Fmt 4703
Sfmt 4703
12697
BELVIQ XR (lorcaserin hydrochloride)
extended-release tablets, 20 mg, were
withdrawn for reasons of safety or
effectiveness.
In 2012, the Agency required the drug
manufacturer to conduct a randomized,
double-blind, placebo-controlled
clinical trial to evaluate the risk of
cardiovascular problems. The
Cardiovascular and Metabolic Effects of
Lorcaserin in Overweight and Obese
Patients—Thrombolysis in Myocardial
Infarction 61 (CAMELLIA–TIMI 61)
clinical trial was conducted to fulfill
this requirement. An analysis of the
CAMELLIA–TIMI 61 trial results
suggests an imbalance in cancer in
humans. Although chance effect cannot
be ruled out, the imbalance persisted
throughout multiple analysis
approaches. The clinical findings
corroborated by the evidence from the
animal models informed the Agency’s
assessment that the risk outweighs any
potential benefits for the current
indications. These findings were
considered clinically meaningful and
could not be adequately addressed
through labeling. Additional evidence
would be necessary to investigate this
signal; however, the Agency has
determined that it is unlikely that the
necessary safety endpoints (i.e., cancer
and reproductive safety) can be readily
or ethically investigated in a clinical
trial. Because preclinical or clinical
studies would first need to be
conducted to address these concerns,
the Agency has determined that this
drug product would not be considered
safe and effective if it were reintroduced
to the market.
FDA issued a Drug Safety
Communication on January 14, 2020,
alerting the public that results from a
clinical trial assessing the risk of heartrelated problems show a possible
increased risk of cancer with BELVIQ
and BELVIQ XR (see https://
www.fda.gov/drugs/drug-safety-andavailability/safety-clinical-trial-showspossible-increased-risk-cancer-weightloss-medicine-belviq-belviq-xr). On
February 13, 2020, FDA announced it
had asked Eisai to voluntarily withdraw
BELVIQ and BELVIQ XR from the U.S.
market (see https://www.fda.gov/drugs/
drug-safety-and-availability/fdarequests-withdrawal-weight-loss-drugbelviq-belviq-xr-lorcaserin-market). On
February 13, 2020, Eisai submitted a
request to FDA to withdraw approval of
NDA 022529 for BELVIQ and NDA
208524 for BELVIQ XR under 21 CFR
314.150(d) and waived its opportunity
for a hearing. As requested by Eisai, the
Agency issued a Federal Register notice
on September 17, 2020 (85 FR 58063),
withdrawing approval of the
E:\FR\FM\04MRN1.SGM
04MRN1
12698
Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices
applications for BELVIQ (lorcaserin
hydrochloride) tablets, 10 mg, and
BELVIQ XR (lorcaserin hydrochloride)
extended-release tablets, 20 mg,
effective September 17, 2020.
Accordingly, the Agency will remove
BELVIQ (lorcaserin hydrochloride)
tablets, 10 mg, and BELVIQ XR
(lorcaserin hydrochloride) extendedrelease tablets, 20 mg, from the list of
drug products published in the Orange
Book. FDA will not accept or approve
ANDAs that refer to this drug product.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04449 Filed 3–3–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
‘‘Low Income Levels’’ Used for Various
Health Professions and Nursing
Programs Authorized in Titles III, VII,
and VIII of the Public Health Service
Act
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is updating income
levels used to identify a ‘‘low income
family’’ for the purpose of determining
eligibility for programs that provide
health professions and nursing training
to individuals from disadvantaged
backgrounds. These various programs
are authorized in Titles III, VII, and VIII
of the Public Health Service Act.
SUPPLEMENTARY INFORMATION: HHS
periodically publishes in the Federal
Register low-income levels to be used
by institutions receiving grants and
cooperative agreements to determine
eligibility for programs providing
training for (1) disadvantaged
individuals, (2) individuals from
disadvantaged backgrounds, or (3)
individuals from low-income families.
Many health professions and nursing
grant and cooperative agreement
awardees use the low-income levels to
determine whether potential program
participants are from an economically
disadvantaged background and would
be eligible to participate in the program,
as well as to determine the amount of
funding the individual receives. Awards
are generally made to accredited schools
of medicine, osteopathic medicine,
public health, dentistry, veterinary
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
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20:27 Mar 03, 2021
Jkt 253001
medicine, optometry, pharmacy, allied
health, podiatric medicine, nursing, and
chiropractic; public or private nonprofit
schools which offer graduate programs
in behavioral health and mental health
practice; and other public or private
nonprofit health or educational entities
to assist individuals from disadvantaged
backgrounds to enter and graduate from
health professions and nursing schools.
Some programs provide for the
repayment of health professions or
nursing education loans for students
from disadvantaged backgrounds.
A ‘‘low-income family/household’’ for
programs included in Titles III, VII, and
VIII of the Public Health Service Act is
defined as having an annual income that
does not exceed 200 percent of the
Department’s poverty guidelines. A
family is a group of two or more
individuals related by birth, marriage, or
adoption who live together.
Most HRSA programs use the income
of a student’s parent(s) to compute low
income status. However, a ‘‘household’’
may potentially be only one person.
Other HRSA programs, depending upon
the legislative intent of the program, the
programmatic purpose related to income
level, as well as the age and
circumstances of the participant, will
apply these low income standards to the
individual student to determine
eligibility, as long as he or she is not
listed as a dependent on the tax form of
his or her parent(s). Each program
announces the rationale and choice of
methodology for determining low
income levels in program funding
opportunities or applications.
Low-income levels are adjusted
annually based on HHS’s poverty
guidelines. HHS’s poverty guidelines
are based on poverty thresholds
published by the U.S. Census Bureau,
adjusted annually for changes in the
Consumer Price Index. The income
figures below have been updated to
reflect the Department’s 2021 poverty
guidelines as published in 86 FR 19
(February 1, 2021).
LOW INCOME LEVELS BASED ON THE
2021 POVERTY GUIDELINES FOR THE
48 CONTIGUOUS STATES AND THE
DISTRICT OF COLUMBIA—Continued
Persons in family/household *
Income level **
8 ............................................
89,320
For families with more than 8 persons, add
$9,080 for each additional person.
* Includes only dependents listed on federal
income tax forms.
** Adjusted gross income for calendar year
2020.
LOW INCOME LEVELS BASED ON THE
2021 POVERTY GUIDELINES FOR
ALASKA
Persons in family/household *
1
2
3
4
5
6
7
8
............................................
............................................
............................................
............................................
............................................
............................................
............................................
............................................
Income level **
$32,180
43,540
54,900
66,260
77,620
88,980
100,340
111,700
For families with more than 8 persons, add
$11,360 for each additional person.
* Includes only dependents listed on federal
income tax forms.
** Adjusted gross income for calendar year
2020.
LOW INCOME LEVELS BASED ON THE
2021 POVERTY GUIDELINES FOR HAWAII
Persons in family/household *
1
2
3
4
5
6
7
8
............................................
............................................
............................................
............................................
............................................
............................................
............................................
............................................
Income level **
$29,640
40,080
50,520
60,960
71,400
81,840
92,280
102,720
For families with more than 8 persons, add
$10,440 for each additional person.
* Includes only dependents listed on federal
income tax forms.
** Adjusted gross income for calendar year
2020.
LOW INCOME LEVELS BASED ON THE
2021 POVERTY GUIDELINES FOR THE
Separate poverty guidelines figures
48 CONTIGUOUS STATES AND THE for Alaska and Hawaii reflect Office of
DISTRICT OF COLUMBIA
Economic Opportunity administrative
Persons in family/household *
1
2
3
4
5
6
7
Income level **
............................................
............................................
............................................
............................................
............................................
............................................
............................................
PO 00000
Frm 00106
Fmt 4703
Sfmt 4703
$25,760
34,840
43,920
53,000
62,080
71,160
80,240
practice beginning in the 1966–1970
period since the U.S. Census Bureau
poverty thresholds do not have separate
figures for Alaska and Hawaii. The
poverty guidelines are not defined for
Puerto Rico or other outlying
jurisdictions. Puerto Rico and other
outlying jurisdictions shall use income
E:\FR\FM\04MRN1.SGM
04MRN1
]]>Agencies
[Federal Register Volume 86, Number 41 (Thursday, March 4, 2021)]
[Notices]
[Pages 12697-12698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04449]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0030]
Determination That BELVIQ (Lorcaserin Hydrochloride) Tablets, 10
Milligrams, and BELVIQ XR (Lorcaserin Hydrochloride) Extended-Release
Tablets, 20 Milligrams, Were 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 BELVIQ (lorcaserin hydrochloride) tablets, 10
milligrams (mg), and BELVIQ XR (lorcaserin hydrochloride) extended-
release tablets, 20 mg, were withdrawn from sale for reasons of safety
or effectiveness. The Agency will not accept or approve abbreviated new
drug applications (ANDAs) for lorcaserin hydrochloride tablets, 10 mg
and 20 mg.
FOR FURTHER INFORMATION CONTACT: Sungjoon Chi, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6216, Silver Spring, MD 20993-0002, 240-
402-9674, [email protected].
SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of
an ANDA to seek approval to market a generic version of a previously
approved drug product. In general, to obtain approval, the ANDA
applicant must show, among other things, that the generic drug product
has the same active ingredient(s); dosage form; route of
administration; strength; conditions of use; and, with certain
exceptions, labeling as the listed drug. In addition, the ANDA
applicant must show that the generic drug product is bioequivalent to
the listed drug.
Section 505(j)(7) of the FD&C Act 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 new drug application (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.
BELVIQ (lorcaserin hydrochloride) tablets, 10 mg, is the subject of
NDA 022529, and BELVIQ XR (lorcaserin hydrochloride) extended-release
tablets, 20 mg, is the subject of NDA 208524, both held by Eisai Inc.
(Eisai), and initially approved on June 27, 2012, and July 15, 2016,
respectively. BELVIQ and BELVIQ XR are indicated as an adjunct to a
reduced-calorie diet and increased physical activity for chronic weight
management in adults with an initial body mass index of:
30 kilograms per square meter (kg/m\2\) or greater
(obese); or
27 kg/m\2\ or greater (overweight) in the presence of at
least one weight-related comorbid condition (e.g., hypertension,
dyslipidemia, type 2 diabetes).
After reviewing Agency records and based on the information we have
at this time, FDA has determined under Sec. 314.161 that BELVIQ
(lorcaserin hydrochloride) tablets, 10 mg, and BELVIQ XR (lorcaserin
hydrochloride) extended-release tablets, 20 mg, were withdrawn for
reasons of safety or effectiveness.
In 2012, the Agency required the drug manufacturer to conduct a
randomized, double-blind, placebo-controlled clinical trial to evaluate
the risk of cardiovascular problems. The Cardiovascular and Metabolic
Effects of Lorcaserin in Overweight and Obese Patients--Thrombolysis in
Myocardial Infarction 61 (CAMELLIA-TIMI 61) clinical trial was
conducted to fulfill this requirement. An analysis of the CAMELLIA-TIMI
61 trial results suggests an imbalance in cancer in humans. Although
chance effect cannot be ruled out, the imbalance persisted throughout
multiple analysis approaches. The clinical findings corroborated by the
evidence from the animal models informed the Agency's assessment that
the risk outweighs any potential benefits for the current indications.
These findings were considered clinically meaningful and could not be
adequately addressed through labeling. Additional evidence would be
necessary to investigate this signal; however, the Agency has
determined that it is unlikely that the necessary safety endpoints
(i.e., cancer and reproductive safety) can be readily or ethically
investigated in a clinical trial. Because preclinical or clinical
studies would first need to be conducted to address these concerns, the
Agency has determined that this drug product would not be considered
safe and effective if it were reintroduced to the market.
FDA issued a Drug Safety Communication on January 14, 2020,
alerting the public that results from a clinical trial assessing the
risk of heart-related problems show a possible increased risk of cancer
with BELVIQ and BELVIQ XR (see https://www.fda.gov/drugs/drug-safety-and-availability/safety-clinical-trial-shows-possible-increased-risk-cancer-weight-loss-medicine-belviq-belviq-xr). On February 13, 2020,
FDA announced it had asked Eisai to voluntarily withdraw BELVIQ and
BELVIQ XR from the U.S. market (see https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market). On February 13, 2020, Eisai
submitted a request to FDA to withdraw approval of NDA 022529 for
BELVIQ and NDA 208524 for BELVIQ XR under 21 CFR 314.150(d) and waived
its opportunity for a hearing. As requested by Eisai, the Agency issued
a Federal Register notice on September 17, 2020 (85 FR 58063),
withdrawing approval of the
[[Page 12698]]
applications for BELVIQ (lorcaserin hydrochloride) tablets, 10 mg, and
BELVIQ XR (lorcaserin hydrochloride) extended-release tablets, 20 mg,
effective September 17, 2020.
Accordingly, the Agency will remove BELVIQ (lorcaserin
hydrochloride) tablets, 10 mg, and BELVIQ XR (lorcaserin hydrochloride)
extended-release tablets, 20 mg, from the list of drug products
published in the Orange Book. FDA will not accept or approve ANDAs that
refer to this drug product.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04449 Filed 3-3-21; 8:45 am]
BILLING CODE 4164-01-P
