[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Pages 47312-47313]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19347]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-P-4186]


Determination That CALCIMAR (calcitonin salmon) Injection, 200 
International Units Per Milliliter, Was Not Withdrawn From Sale for 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 or Agency) has 
determined that CALCIMAR (calcitonin salmon) Injection, 200 
International Units per milliliter (IU/mL), was not withdrawn from sale 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 CALCIMAR 
(calcitonin salmon) Injection, 200 IU/mL, if all other legal and 
regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT: Nam Kim, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6272, Silver Spring, MD 20993-0002, 301-796-3472.

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.
    CALCIMAR (calcitonin salmon) injection, 200 IU/mL, is the subject 
of NDA 017769, held by Sanofi Aventis, and initially approved on April 
17, 1978. CALCIMAR is indicated for Paget's disease of bone, 
hypercalcemia, and postmenopausal osteoporosis.
    CALCIMAR (calcitonin salmon) injection, 200 IU/mL, is currently 
listed

[[Page 47313]]

in the ``Discontinued Drug Product List'' section of the Orange Book.
    Lachman Consultant Services, Inc. submitted a citizen petition 
dated December 1, 2016 (Docket No. FDA-2016-P-4186), under 21 CFR 
10.30, requesting that the Agency determine whether CALCIMAR 
(calcitonin salmon) injection, 200 IU/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 CALCIMAR (calcitonin salmon) injection, 200 
IU/mL, was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
CALCIMAR (calcitonin salmon) injection, 200 IU/mL, was withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of CALCIMAR (calcitonin 
salmon) injection, 200 IU/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 CALCIMAR (calcitonin 
salmon) injection, 200 IU/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 this drug product 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: September 3, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-19347 Filed 9-6-19; 8:45 am]
BILLING CODE 4164-01-P