[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]


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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Milliliter in a 10 Milliliter Vial, Was Not Withdrawn From Sale for 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.

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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a 10 milliliter vial, was not withdrawn from sale for reasons of safety 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