Determination That MIACALCIN (Calcitonin Salmon) Injection, 100 USP Units/Milliliter (mL), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 10342-10343 [2023-03389]
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Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices
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Dated: February 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–03370 Filed 2–16–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–P–2517]
Determination That MIACALCIN
(Calcitonin Salmon) Injection, 100 USP
Units/Milliliter (mL), 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Withdrawn From Sale for Reasons of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, Agency, or we)
has determined that MIACALCIN
(calcitonin salmon) injection, 100 USP
Units/milliliter (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withdrawn from sale for reasons of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 calcitonin
salmon injection, 100 USP Units/mL, if
all other legal and regulatory
requirements are met.
FOR FURTHER INFORMATION CONTACT:
Donna Tran, Center for Drug Evaluation
and Research, Food and Drug
SUMMARY:
PO 00000
Frm 00062
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Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6213, Silver Spring,
MD 20993–0002, 301–796–3600,
Donna.Tran@fda.hhs.gov.
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 market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
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 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.
MIACALCIN (calcitonin salmon)
injection, 100 USP Units/mL, is the
subject of NDA 017808, held by Mylan
Ireland Ltd., and initially approved on
July 3, 1986. MIACALCIN is indicated
for: (1) the treatment of symptomatic
Paget’s disease of bone in patients with
moderate to severe disease characterized
by polyostotic involvement with
elevated serum alkaline phosphatase
and urinary hydroxyproline excretion;
(2) early treatment of hypercalcemic
emergencies, along with other
appropriate agents, when a rapid
decrease in serum calcium is required,
until more specific treatment of the
underlying disease can be
E:\FR\FM\17FEN1.SGM
17FEN1
lotter on DSK11XQN23PROD with NOTICES1
Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices
accomplished; and (3) treatment of
postmenopausal osteoporosis in women
greater than 5 years postmenopause.
MIACALCIN (calcitonin salmon)
injection, 100 USP Units/mL, is
currently listed in the ‘‘Discontinued
Drug Product List’’ section of the Orange
Book.
Maiva Pharma Private Ltd. submitted
a citizen petition dated October 12, 2022
(Docket No. FDA–2022–P–2517), under
21 CFR 10.30, requesting that the
Agency determine whether MIACALCIN
(calcitonin salmon) injection, 100 USP
Units/mL, was voluntarily withdrawn
for reasons other than safety or efficacy.
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 MIACALCIN (calcitonin
salmon) injection, 100 USP Units/mL,
was not withdrawn for reasons of safety
or effectiveness. The petitioner has
identified no data or other information
suggesting that MIACALCIN (calcitonin
salmon) injection, 100 USP Units/mL,
was withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of
MIACALCIN (calcitonin salmon)
injection, 100 USP Units/mL, 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 this drug product was
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list MIACALCIN (calcitonin
salmon) injection, 100 USP Units/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 MIACALCIN (calcitonin salmon)
injection, 100 USP Units/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: February 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–03389 Filed 2–16–23; 8:45 am]
BILLING CODE 4164–01–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–2391]
Miles Laboratories Inc.; Withdrawal of
Approval of an Abbreviated New Drug
Application for Alcohol and Dextrose
Injection; 5 Milliliters/100 Milliliters, 5
Grams/100 Milliliters
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of an abbreviated
new drug application (ANDA) for
Alcohol and Dextrose Injection, 5
milliliters (mL)/100 mL, 5 grams (g)/100
mL. The bases for the withdrawal are
that the ANDA holder has repeatedly
failed to file required annual reports for
this ANDA and that the Agency has
scientific data and experience to show
that the drug product under this ANDA
is unsafe for use under the conditions of
use for which the product was
approved.
DATES: Approval is withdrawn as of
February 17, 2023.
FOR FURTHER INFORMATION CONTACT:
Kaetochi Okemgbo, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6224,
Silver Spring, MD 20993–0002, 301–
796–1546, Kaetochi.Okemgbo@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: The
holder of an approved ANDA to market
a new drug for human use is required
to submit annual reports to FDA
concerning its approved ANDA under
§§ 314.81 and 314.98 (21 CFR 314.81
and 314.98). Additionally, under 21
CFR 314.161, FDA previously
determined that Alcohol and Dextrose
Injection, 5 mL/100 mL, 5 g/100 mL,
approved under ANDA 083483 was
withdrawn from sale for safety and
effectiveness reasons (see 86 FR 72606,
December 22, 2021) (this determination
also applied to other applications and to
the 10 mL/100 mL, 5 g/100 mL strength
of Alcohol and Dextrose Injection
approved under new drug application
(NDA) 004589). As explained in our
Federal Register notice determining that
Alcohol and Dextrose was withdrawn
from sale for safety and effectiveness
reasons, Alcohol and Dextrose Injection
is indicated to provide increased caloric
intake. The use of Alcohol and Dextrose
raises several safety concerns because
there are many risks associated with the
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
10343
exposure to alcohol. Alcohol is
contraindicated for use in patients with
neurologic disorders, such as seizures,
who have current or past substance
abuse problems, or who are pregnant. It
can cause intoxication, respiratory
depression, and disturbances in serum
glucose levels. FDA-approved
alternatives for intravenous calorie
supplementation that do not include
alcohol were approved after these
Alcohol and Dextrose products and are
available today.
In the Federal Register of October 24,
2022 (87 FR 64227), FDA published a
notice of opportunity for a hearing
(NOOH) on a proposal to withdraw
approval of ANDA 083483, held by
Miles Laboratories Inc., the last holder
of record, under § 314.150(b)(1) (21 CFR
314.150(b)(1)) because the ANDA holder
has repeatedly failed to submit the
required annual reports and under
§ 314.150(a)(2)(i) because the Agency
has scientific data and experience to
show that the drug product approved
under ANDA 083483, Alcohol and
Dextrose Injection, 5 mL/100 mL, 5 g/
100 mL, is unsafe for use under the
conditions of use for which the product
was approved. The ANDA holder did
not respond to the NOOH. Failure to file
a written notice of participation and
request for hearing as required by
§ 314.200 (21 CFR 314.200) constitutes a
waiver of the opportunity for a hearing
by the ANDA holder concerning the
proposal to withdraw approval of the
ANDA and a waiver of any contentions
concerning the legal status of the drug
product. Accordingly, FDA is
withdrawing approval of ANDA 083483.
Therefore, for reasons discussed
above, FDA finds that: (1) the ANDA
holder has failed to submit reports
required under §§ 314.81 and 314.98
and section 505(k) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 355(k)) and (2) the Agency has
scientific data and experience to show
that the drug product approved under
ANDA 083483, Alcohol and Dextrose
Injection, 5 mL/100 mL, 5 g/100 mL, is
unsafe for use under the conditions of
use for which the product was
approved. In addition, under § 314.200,
FDA finds that the ANDA holder has
waived its opportunity for a hearing and
any contentions concerning the legal
status of the drug products. Therefore,
based on these findings and pursuant to
the authority under section 505(e) of the
FD&C Act, approval of ANDA 083483
and all amendments and supplements
thereto is hereby withdrawn as of
February 17, 2023.
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]]>Agencies
[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10342-10343]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03389]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-2517]
Determination That MIACALCIN (Calcitonin Salmon) Injection, 100
USP Units/Milliliter (mL), 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, Agency, or we) has
determined that MIACALCIN (calcitonin salmon) injection, 100 USP Units/
milliliter (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 calcitonin salmon injection, 100 USP
Units/mL, if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Donna Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-796-3600,
[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 market a generic version of a previously approved drug
product. To obtain approval, the ANDA applicant must show, among other
things, that the generic drug product: (1) has the same active
ingredient(s), dosage form, route of administration, strength,
conditions of use, and (with certain exceptions) labeling as the listed
drug, which is a version of the drug that was previously approved and
(2) is bioequivalent to the listed drug. ANDA applicants do not have to
repeat the extensive clinical testing otherwise necessary to gain
approval of a new drug application (NDA).
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 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.
MIACALCIN (calcitonin salmon) injection, 100 USP Units/mL, is the
subject of NDA 017808, held by Mylan Ireland Ltd., and initially
approved on July 3, 1986. MIACALCIN is indicated for: (1) the treatment
of symptomatic Paget's disease of bone in patients with moderate to
severe disease characterized by polyostotic involvement with elevated
serum alkaline phosphatase and urinary hydroxyproline excretion; (2)
early treatment of hypercalcemic emergencies, along with other
appropriate agents, when a rapid decrease in serum calcium is required,
until more specific treatment of the underlying disease can be
[[Page 10343]]
accomplished; and (3) treatment of postmenopausal osteoporosis in women
greater than 5 years postmenopause.
MIACALCIN (calcitonin salmon) injection, 100 USP Units/mL, is
currently listed in the ``Discontinued Drug Product List'' section of
the Orange Book.
Maiva Pharma Private Ltd. submitted a citizen petition dated
October 12, 2022 (Docket No. FDA-2022-P-2517), under 21 CFR 10.30,
requesting that the Agency determine whether MIACALCIN (calcitonin
salmon) injection, 100 USP Units/mL, was voluntarily withdrawn for
reasons other than safety or efficacy.
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 MIACALCIN (calcitonin salmon) injection, 100
USP Units/mL, was not withdrawn for reasons of safety or effectiveness.
The petitioner has identified no data or other information suggesting
that MIACALCIN (calcitonin salmon) injection, 100 USP Units/mL, was
withdrawn for reasons of safety or effectiveness. We have carefully
reviewed our files for records concerning the withdrawal of MIACALCIN
(calcitonin salmon) injection, 100 USP Units/mL, 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 this drug product was withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will continue to list MIACALCIN (calcitonin
salmon) injection, 100 USP Units/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 MIACALCIN (calcitonin salmon)
injection, 100 USP Units/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: February 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03389 Filed 2-16-23; 8:45 am]
BILLING CODE 4164-01-P
