Determination That QUELICIN PRESERVATIVE FREE (Succinylcholine Chloride) Injection, 20 Milligrams/Milliliter, 50 Milligrams/Milliliter, and 100 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 30320-30321 [2021-11802]
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30320
Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS—Continued
Type of respondent
PHEP Awardees: Major Metropolitan Area Jurisdictions.
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–11872 Filed 6–4–21; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–P–2317]
Determination That QUELICIN
PRESERVATIVE FREE
(Succinylcholine Chloride) Injection, 20
Milligrams/Milliliter, 50 Milligrams/
Milliliter, and 100 Milligrams/Milliliter,
Was Not Withdrawn From Sale for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 QUELICIN
PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 milligrams (mg)/
milliliter (mL), 50 mg/mL, and 100 mg/
mL, was not withdrawn from sale for
reasons of safety or effectiveness. This
determination will allow FDA to
approve abbreviated new drug
applications (ANDAs) for QUELICIN
PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/
mL, and 100 mg/mL, if all other legal
and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT:
Nikki Mueller, Center for Drug
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:36 Jun 04, 2021
Vaccination of critical workforce
(functional exercise, full-scale exercise, or incident).
Vaccination of critical workforce
(point of dispensing/dispensing/
vaccination clinic setup).
Vaccination of critical workforce (immunization information system).
Five-year distribution FSE OR fiveyear pandemic influenza full-scale
exercise.
Facility setup drill .............................
Site activation drill ............................
Staff notification and assembly drill
Dispensing throughput drill ..............
Five-year dispensing full-scale exercise or incident.
Five-year dispensing full-scale exercise for each point of dispensing
site exercised.
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280,
Silver Spring, MD 20993–0002, 301–
796–3601, Nicole.Mueller@fda.hhs.gov.
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).
SUPPLEMENTARY INFORMATION:
Jkt 253001
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
Number of
respondents
Form name
Avg. burden
per response
(in hours)
62
1
12/60
62
1
12/60
62
1
12/60
62
1
0.5
4
4
4
4
4
1
1
1
1
1
45/60
1
1
12/60
6/60
4
1
6/60
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.
QUELICIN PRESERVATIVE FREE
(succinylcholine chloride) Injection, 20
mg/mL, 50 mg/mL, and 100 mg/mL, is
the subject of NDA 008845, held by
Hospira, Inc., and initially approved on
May 1, 1953. QUELICIN
PRESERVATIVE FREE is indicated as an
adjunct to general anesthesia, to
facilitate tracheal intubation, and to
provide skeletal muscle relaxation
during surgery or mechanical
ventilation.
Baxter Healthcare Corp. submitted a
citizen petition dated December 21,
2020 (Docket No. FDA–2020–P–2317),
under 21 CFR 10.30, requesting that the
Agency determine whether QUELICIN
PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/
mL, and 100 mg/mL, was 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
§ 314.161 that QUELICIN
PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/
mL, and 100 mg/mL, was not
withdrawn for reasons of safety or
E:\FR\FM\07JNN1.SGM
07JNN1
Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Notices
effectiveness. The petitioner has
identified no data or other information
suggesting that QUELICIN
PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/
mL, and 100 mg/mL, was withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
QUELICIN PRESERVATIVE FREE
(succinylcholine chloride) Injection, 20
mg/mL, 50 mg/mL, and 100 mg/mL,
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 QUELICIN
PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/
mL, and 100 mg/mL, 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 QUELICIN PRESERVATIVE FREE
(succinylcholine chloride) Injection, 20
mg/mL, 50 mg/mL, and 100 mg/mL,
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: May 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–11802 Filed 6–4–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
khammond on DSKJM1Z7X2PROD with NOTICES
[Docket No. FDA–2020–P–2174]
Determination That ATROVENT
(Ipratropium Bromide) Metered Spray,
0.021 Micrograms/Spray and 0.042
Micrograms/Spray, Were Not
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
SUMMARY:
VerDate Sep<11>2014
17:36 Jun 04, 2021
Jkt 253001
determined that ATROVENT
(ipratropium bromide) metered spray,
0.021 micrograms (mcg)/spray and 0.042
mcg/spray, were not withdrawn from
sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
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,
Stacy.Kane@fda.hhs.gov.
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 (§ 314.161 (21 CFR 314.161)).
SUPPLEMENTARY INFORMATION:
PO 00000
Frm 00072
Fmt 4703
Sfmt 4703
30321
FDA may not approve an ANDA that
does not refer to a listed drug.
ATROVENT (ipratropium bromide)
metered spray, 0.021 mcg/spray, is the
subject of NDA 020393 and ATROVENT
(ipratropium bromide) metered spray,
0.042 mcg/spray, is the subject of NDA
020394, both held by Boehringer
Ingelheim Pharmaceuticals, Inc., and
initially approved on October 20, 1995.
ATROVENT is indicated for the
symptomatic relief of rhinorrhea
associated with allergic and nonallergic
perennial rhinitis in adults and children
age 6 years and older.
In letters dated December 22, 2017,
Boehringer Ingelheim Pharmaceuticals,
Inc., requested withdrawal of NDA
020393 and NDA 020394 for
ATROVENT (ipratropium bromide). In
the Federal Register of July 12, 2018 (83
FR 32305), FDA announced that it was
withdrawing approval of NDA 020393
and NDA 020394, effective August 13,
2018.
Lachman Consulting Services, Inc.,
submitted a citizen petition dated
November 5, 2020 (Docket No. FDA–
2020–P–2174), under 21 CFR 10.30,
requesting that the Agency determine
whether ATROVENT (ipratropium
bromide) metered spray, 0.021 mcg/
spray and 0.042 mcg/spray, 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
§ 314.161 that ATROVENT (ipratropium
bromide) metered spray, 0.021 mcg/
spray and 0.042 mcg/spray, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that ATROVENT
(ipratropium bromide) metered spray,
0.021 mcg/spray and 0.042 mcg/spray,
were withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
ATROVENT (ipratropium bromide)
metered spray, 0.021 mcg/spray and
0.042 mcg/spray, 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 drug products were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list ATROVENT
(ipratropium bromide) metered spray,
0.021 mcg/spray and 0.042 mcg/spray,
in the ‘‘Discontinued Drug Product List’’
section of the Orange Book. The
‘‘Discontinued Drug Product List’’
E:\FR\FM\07JNN1.SGM
07JNN1
]]>Agencies
[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Notices]
[Pages 30320-30321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11802]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-P-2317]
Determination That QUELICIN PRESERVATIVE FREE (Succinylcholine
Chloride) Injection, 20 Milligrams/Milliliter, 50 Milligrams/
Milliliter, and 100 Milligrams/Milliliter, Was 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 QUELICIN PRESERVATIVE FREE (succinylcholine chloride)
Injection, 20 milligrams (mg)/milliliter (mL), 50 mg/mL, and 100 mg/mL,
was not withdrawn from sale for reasons of safety or effectiveness.
This determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for QUELICIN PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, if all other
legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Nikki Mueller, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3601, [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
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.
QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20
mg/mL, 50 mg/mL, and 100 mg/mL, is the subject of NDA 008845, held by
Hospira, Inc., and initially approved on May 1, 1953. QUELICIN
PRESERVATIVE FREE is indicated as an adjunct to general anesthesia, to
facilitate tracheal intubation, and to provide skeletal muscle
relaxation during surgery or mechanical ventilation.
Baxter Healthcare Corp. submitted a citizen petition dated December
21, 2020 (Docket No. FDA-2020-P-2317), under 21 CFR 10.30, requesting
that the Agency determine whether QUELICIN PRESERVATIVE FREE
(succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/
mL, was 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 QUELICIN PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, was not
withdrawn for reasons of safety or
[[Page 30321]]
effectiveness. The petitioner has identified no data or other
information suggesting that QUELICIN PRESERVATIVE FREE (succinylcholine
chloride) Injection, 20 mg/mL, 50 mg/mL, and 100 mg/mL, was withdrawn
for reasons of safety or effectiveness. We have carefully reviewed our
files for records concerning the withdrawal of QUELICIN PRESERVATIVE
FREE (succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100
mg/mL, 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 QUELICIN PRESERVATIVE
FREE (succinylcholine chloride) Injection, 20 mg/mL, 50 mg/mL, and 100
mg/mL, 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
QUELICIN PRESERVATIVE FREE (succinylcholine chloride) Injection, 20 mg/
mL, 50 mg/mL, and 100 mg/mL, 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: May 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11802 Filed 6-4-21; 8:45 am]
BILLING CODE 4164-01-P
