[Federal Register Volume 83, Number 112 (Monday, June 11, 2018)]
[Notices]
[Pages 27010-27011]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-12441]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-P-0327]


Determination That MUTAMYCIN (Mitomycin) Injectable, 5 
Milligrams/Vial and 20 Milligrams/Vial, Was Not Withdrawn From Sale for 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 MUTAMYCIN (mitomycin) injectable, 5 milligrams (mg)/
vial and 20 mg/vial, was not withdrawn from sale for reasons of safety 
or effectiveness. This determination will allow FDA to approve 
abbreviated new drug applications (ANDAs) for MUTAMYCIN (mitomycin) 
injectable, 5 mg/vial and 20 mg/vial, if all other legal and regulatory 
requirements are met.

FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation

[[Page 27011]]

and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363, 
[email protected].

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.
    MUTAMYCIN (mitomycin) injectable, 5 mg/vial and 20 mg/vial, is the 
subject of NDA 050450, held by Bristol Laboratories Inc., and initially 
approved on May 28, 1974. MUTAMYCIN has been shown to be useful in the 
therapy of disseminated adenocarcinoma of the stomach or pancreas in 
proven combinations with other approved chemotherapeutic agents and as 
palliative treatment when other modalities have failed. MUTAMYCIN 
(mitomycin) injectable, 5 mg/vial and 20 mg/vial, is currently listed 
in the ``Discontinued Drug Product List'' section of the Orange Book.
    Fresenius Kabi USA, LLC submitted a citizen petition dated January 
22, 2018 (Docket No. FDA-2018-P-0327), under 21 CFR 10.30, requesting 
that the Agency determine whether MUTAMYCIN (mitomycin) injectable, 5 
mg/vial and 20 mg/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 MUTAMYCIN (mitomycin) injectable, 5 mg/vial 
and 20 mg/vial, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that this product was withdrawn for reasons of 
safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of MUTAMYCIN (mitomycin) injectable, 
5 mg/vial and 20 mg/vial, 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 MUTAMYCIN (mitomycin) 
injectable, 5 mg/vial and 20 mg/vial, in the ``Discontinued Drug 
Product List'' section of the Orange Book. The ``Discontinued Drug 
Product List'' identifies 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: June 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-12441 Filed 6-8-18; 8:45 am]
 BILLING CODE 4164-01-P