[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]
-----------------------------------------------------------------------
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International Units Per Milliliter, Was Not Withdrawn From Sale for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.
-----------------------------------------------------------------------
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International Units per milliliter (IU/mL), was not withdrawn from sale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