[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]


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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USP Units/Milliliter (mL), Was Not Withdrawn From Sale for Reasons of 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milliliter (mL), was not withdrawn from sale for reasons of safety or 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, 
[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FDA determines that the listed drug was withdrawn from sale for reasons 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


