[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Notices]
[Pages 16273-16274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07828]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-P-3949]


Determination That TRISENOX (Arsenic Trioxide) Injection, 1 
Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety 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 TRISENOX (arsenic trioxide) injection, 1 milligram 
(mg)/milliliter (mL), was not withdrawn from sale for reasons of safety 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: Stacy Kane, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363.

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

[[Page 16274]]

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.
    TRISENOX (arsenic trioxide) injection, 1 mg/mL, is the subject of 
NDA 021248, held by Cephalon, Inc., and initially approved on September 
25, 2000. TRISENOX is indicated in combination with tretinoin for 
treatment of adults with newly diagnosed low-risk acute promyelocytic 
leukemia (APL) whose APL is characterized by the presence of the 
t(15;17) translocation or PML/RAR-alpha gene expression; and for 
induction of remission and consolidation in patients with APL who are 
refractory to, or have relapsed from, retinoid and anthracycline 
chemotherapy, and whose APL is characterized by the presence of the 
t(15;17) translocation or PML/RAR-alpha gene expression.
    In a letter dated February 21, 2018, the sponsor notified FDA that 
TRISENOX (arsenic trioxide) injection, 1 mg/mL, was being discontinued, 
and FDA moved the drug product to the ``Discontinued Drug Product 
List'' section of the Orange Book.
    Lachman Consultant Services, Inc., submitted a citizen petition 
dated October 17, 2018 (Docket No. FDA-2018-P-3949), under 21 CFR 
10.30, requesting that the Agency determine whether TRISENOX (arsenic 
trioxide) injection, 1 mg/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 TRISENOX (arsenic trioxide) injection, 1 mg/
mL, was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
TRISENOX (arsenic trioxide) injection, 1 mg/mL, was withdrawn for 
reasons of safety or effectiveness. We have carefully reviewed our 
files for records concerning the withdrawal of TRISENOX (arsenic 
trioxide) injection, 1 mg/mL, 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 TRISENOX (arsenic 
trioxide) injection, 1 mg/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. 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.

    Dated: April 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07828 Filed 4-17-19; 8:45 am]
 BILLING CODE 4164-01-P


