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That ATROVENT (Ipratropium Bromide) Metered Spray, 0.021 Micrograms/Spray and 0.042 Micrograms/Spray, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 30321-30322 [2021-11800]
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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mL, and 100 mg/mL, was withdrawn for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product was not withdrawn from sale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Withdrawn From Sale for Reasons of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
30322
Federal Register / Vol. 86, No. 107 / Monday, June 7, 2021 / Notices
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
FDA will not begin procedures to
withdraw approval of approved ANDAs
that refer to these drug products.
Additional ANDAs for this drug product
may also 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: May 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–11800 Filed 6–4–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
khammond on DSKJM1Z7X2PROD with NOTICES
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; MultiComponent Application.
Date: July 21, 2021.
Time: 12:45 p.m. to 5:15 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Video Meeting).
Contact Person: Dario Dieguez, Jr., Ph.D.,
Scientific Review Officer, Scientific Review
Branch, National Institute on Aging, National
Institutes of Health, Gateway Building, Suite
2W200, 7201 Wisconsin Avenue, Bethesda,
MD 20892, 301.827.3101, dario.dieguez@
nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
VerDate Sep<11>2014
17:36 Jun 04, 2021
Jkt 253001
Dated: June 2, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–11880 Filed 6–4–21; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; NIDDK F99/K99
Special Emphasis Panel.
Date: June 23, 2021.
Time: 12:00 p.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Virtual
Meeting).
Contact Person: Peter J. Kozel, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
6707 Democracy Boulevard, Room 7119,
Bethesda, MD 20892–5452, 301–594–7271,
koezelp@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.847, Diabetes,
Endocrinology and Metabolic Research;
93.848, Digestive Diseases and Nutrition
Research; 93.849, Kidney Diseases, Urology
and Hematology Research, National Institutes
of Health, HHS)
Dated: June 2, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–11881 Filed 6–4–21; 8:45 am]
BILLING CODE 4140–01–P
PO 00000
Frm 00073
Fmt 4703
Sfmt 4703
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Cancer Institute; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Cancer
Institute Special Emphasis Panel; PLCO
Biospecimens Resource U01 SEP.
Date: July 1, 2021.
Time: 10:00 a.m. to 2:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W102, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Shakeel Ahmad, Ph.D.,
Branch Chief, Research Technology and
Contract Review Branch, Division of
Extramural Activities, National Cancer
Institute, NIH, 9609 Medical Center Drive,
Room 7W102, Rockville, Maryland 20850,
240–276–6442, ahmads@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel;
Collaborative Research at the NIH Clinical
Center (U01).
Date: July 1, 2021.
Time: 11:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute at Shady
Grove, 9609 Medical Center Drive, Room
7W240, Rockville, Maryland 20850
(Telephone Conference Call).
Contact Person: Hasan Siddiqui, Ph.D.,
Scientific Review Officer, Special Review
Branch, Division of Extramural Activities,
National Cancer Institute, NIH, 9609, Medical
Center Drive, Room 7W240, Rockville,
Maryland 20850, 240–276–5122,
hasan.siddiqui@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.392, Cancer Construction;
93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and
Diagnosis Research; 93.395, Cancer
Treatment Research; 93.396, Cancer Biology
Research; 93.397, Cancer Centers Support;
93.398, Cancer Research Manpower; 93.399,
Cancer Control, National Institutes of Health,
HHS)
E:\FR\FM\07JNN1.SGM
07JNN1
]]>Agencies
[Federal Register Volume 86, Number 107 (Monday, June 7, 2021)]
[Notices]
[Pages 30321-30322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-11800]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) has
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,
[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.
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 Sec. 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''
[[Page 30322]]
delineates, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness.
FDA will not begin procedures to withdraw approval of approved
ANDAs that refer to these drug products. Additional ANDAs for this drug
product may also 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: May 27, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-11800 Filed 6-4-21; 8:45 am]
BILLING CODE 4164-01-P
