Notice2023-03389
Determination That MIACALCIN (Calcitonin Salmon) Injection, 100 USP Units/Milliliter (mL), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
February 17, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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Agency, or we) has determined that MIACALCIN (calcitonin salmon) injection, 100 USP Units/ milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness.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.
Full Text
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<title>Federal Register, Volume 88 Issue 33 (Friday, February 17, 2023)</title>
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[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10342-10343]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-03389]
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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USP Units/Milliliter (mL), Was Not Withdrawn From Sale for Reasons of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.
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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milliliter (mL), was not withdrawn from sale for reasons of safety or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,
<a href="/cdn-cgi/l/email-protection#c98da6a7a7a8e79dbba8a789afada8e7a1a1bae7aea6bf"><span class="__cf_email__" data-cfemail="de9ab1b0b0bff08aacbfb09eb8babff0b6b6adf0b9b1a8">[email protected]</span></a>.
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
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