[Federal Register Volume 89, Number 223 (Tuesday, November 19, 2024)]
[Notices]
[Page 91410]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-26915]
[[Page 91410]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-P-3482]
Determination That JESDUVROQ (daprodustat) Tablets, 1 Milligram,
2 Milligrams, 4 Milligrams, 6 Milligrams, and 8 Milligrams, Were 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Withdrawn From Sale for Reasons of Safety or Effectiveness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 JESDUVROQ (daprodustat) tablets, 1 milligram (mg), 2
mg, 4 mg, 6 mg, and 8 mg, were not withdrawn from sale for reasons of
safety or effectiveness. This determination will allow FDA to approve
abbreviated new drug applications (ANDAs) for JESDUVROQ (daprodustat)
tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Awo Archampong-Gray, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6243, Silver Spring, MD 20993-0002, 301-
796-0110, [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.
JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg,
are the subject of NDA 216951, held by GlaxoSmithKline Intellectual
Property (No. 2) Limited England, and initially approved on February 1,
2023. JESDUVROQ is a hypoxia-inducible factor prolyl hydroxylase (HIF
PH) inhibitor indicated for the treatment of anemia due to chronic
kidney disease in adults who have been receiving dialysis for at least
4 months. JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and
8 mg, are currently listed in the ``Discontinued Drug Product List''
section of the Orange Book.
Qilu Pharmaceutical (Hainan) Co., Ltd., submitted a citizen
petition dated July 24, 2024 (Docket No. FDA-2024-P-3482), under 21 CFR
10.30, requesting that the Agency determine whether JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, were 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 JESDUVROQ (daprodustat) tablets, 1 mg, 2 mg, 4
mg, 6 mg, and 8 mg, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that JESDUVROQ (daprodustat) tablets, 1 mg, 2
mg, 4 mg, 6 mg, and 8 mg, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of JESDUVROQ (daprodustat) tablets, 1 mg, 2
mg, 4 mg, 6 mg, and 8 mg, 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 JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, and 8 mg, 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. ANDAs that refer to JESDUVROQ
(daprodustat) tablets, 1 mg, 2 mg, 4 mg, 6 mg, or 8 mg, may 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: November 7, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-26915 Filed 11-18-24; 8:45 am]
BILLING CODE 4164-01-P