[Federal Register Volume 82, Number 50 (Thursday, March 16, 2017)]
[Notices]
[Pages 14002-14003]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05246]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-P-1676]
Determination that CYANOCOBALAMIN INJECTION, 1 Milligram per
Milliliter in a 10 Milliliter Vial, Was Not Withdrawn From Sale for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 CYANOCOBALAMIN INJECTION, 1 milligram per milliliter in
a 10 milliliter vial, was not withdrawn from sale for reasons of safety
or effectiveness. This determination means that FDA will not begin
procedures to withdraw approval of abbreviated new drug applications
(ANDAs) that refer to this drug product, and it will allow FDA to
continue to approve ANDAs that refer to the product as long as they
meet relevant legal and regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Elizabeth Trentacost, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6219, Silver Spring, MD 20993-0002, 240-
402-7736.
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, dosage form, and route of administration 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 (21 CFR 314.161). FDA may not approve an ANDA that does not refer
to a listed drug.
CYANOCOBALAMIN INJECTION, 1 milligram per milliliter in a 10
milliliter vial, is the subject of ANDA 080557, held by Fresenius Kabi
USA (Fresenius), and initially approved on June 20, 1973.
CYANOCOBALAMIN INJECTION is indicated for vitamin B12
deficiencies due to malabsorption that may be associated with the
following conditions: Addisonian (pernicious) anemia; gastrointestinal
pathology, dysfunction, or surgery, including gluten enteropathy or
sprue, small bowel bacterial overgrowth, and total or partial
gastrectomy; fish tapeworm
[[Page 14003]]
infestation; malignancy of pancreas or bowel; or folic acid deficiency.
In a letter dated December 21, 2016, Fresenius notified FDA that
CYANOCOBALAMIN INJECTION, 1 milligram per milliliter in a 10 milliliter
vial, was discontinued over 30 years ago, and Fresenius had concluded
that the drug was discontinued for reasons other than safety or
effectiveness. Fresenius also conveyed that they currently manufacture
and market a 1 milliliter multiple dose vial of the 1 milligram per
milliliter concentration.
John R. Rapoza submitted a citizen petition dated June 16, 2016
(Docket No. FDA-2016-P-1676), under 21 CFR 10.30, requesting that the
Agency determine whether CYANOCOBALAMIN INJECTION, 1 milligram per
milliliter in a 10 milliliter vial, 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 CYANOCOBALAMIN INJECTION, 1 milligram per
milliliter in a 10 milliliter vial, was not withdrawn for reasons of
safety or effectiveness. The petitioner has identified no data or other
information suggesting that CYANOCOBALAMIN INJECTION, 1 milligram per
milliliter in a 10 milliliter vial, was withdrawn for reasons of safety
or effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of CYANOCOBALAMIN INJECTION, 1 milligram per
milliliter in a 10 milliliter vial, 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 list CYANOCOBALAMIN INJECTION, 1
milligram per milliliter in a 10 milliliter vial, 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. FDA will not begin procedures to withdraw approval of
approved ANDAs that refer to this drug product. Additional ANDAs for
this drug product may also 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: March 13, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05246 Filed 3-15-17; 8:45 am]
BILLING CODE 4164-01-P