[Federal Register Volume 89, Number 83 (Monday, April 29, 2024)]
[Notices]
[Page 33370]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-P-5450]


Determination That FLUDARABINE PHOSPHATE Injection, 50 
Milligrams/2 Milliliter, Was Not Withdrawn From Sale for Reasons of 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, Agency, or we) has 
determined that FLUDARABINE PHOSPHATE Injection, 50 milligrams (mg)/2 
milliliter (mL), was not withdrawn from sale for reasons of safety or 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: Kaetochi Okemgbo, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301-
796-1546, [email protected].

SUPPLEMENTARY INFORMATION: Section 505(j) of the Federal Food, Drug, 
and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)) allows the submission of 
an ANDA to market a generic version of a previously approved drug 
product. To obtain approval, the ANDA applicant must show, among other 
things, that the generic drug product: (1) has the same active 
ingredient(s), dosage form, route of administration, strength, 
conditions of use, and (with certain exceptions) labeling as the listed 
drug, which is a version of the drug that was previously approved, and 
(2) is bioequivalent to the listed drug. ANDA applicants do not have to 
repeat the extensive clinical testing otherwise necessary to gain 
approval of a new drug application (NDA).
    Section 505(j)(7) of the FD&C Act 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.
    FLUDARABINE PHOSPHATE Injection, 50 mg/2 mL, is the subject of NDA 
022137, held by Sandoz Inc., and initially approved on September 21, 
2007. FLUDARABINE PHOSPHATE Injection is indicated for the treatment of 
adult patients with B-cell chronic lymphocytic leukemia who have not 
responded to or whose disease has progressed during treatment with at 
least one standard alkylating-agent containing regimen. The drug 
product is currently listed in the ``Discontinued Drug Product List'' 
section of the Orange Book.
    Hisun Pharmaceutical (Hangzhou) Co., Ltd. submitted a citizen 
petition dated December 12, 2023 (Docket No. FDA-2023-P-5450), under 21 
CFR 10.30, requesting that the Agency determine whether FLUDARABINE 
PHOSPHATE Injection, 50 mg/2 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 FLUDARABINE PHOSPHATE Injection, 50 mg/2 mL, 
was not withdrawn for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
FLUDARABINE PHOSPHATE Injection, 50 mg/2 mL, was withdrawn for reasons 
of safety or effectiveness. We have carefully reviewed our files for 
records concerning the withdrawal of FLUDARABINE PHOSPHATE Injection, 
50 mg/2 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 FLUDARABINE PHOSPHATE 
Injection, 50 mg/2 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 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09050 Filed 4-26-24; 8:45 am]
BILLING CODE 4164-01-P