[Federal Register Volume 88, Number 159 (Friday, August 18, 2023)]
[Notices]
[Page 56635]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-17746]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-P-1549]
Determination That BORTEZOMIB (Bortezomib) Solution, 2.5
Milligrams/Milliliter and 3.5 Milligrams/1.4 Milliliter (2.5
Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of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 BORTEZOMIB (bortezomib) solution, 2.5 milligrams (mg)/
milliliter (mL) and 3.5 mg/1.4 mL (2.5 mg/mL), was not withdrawn from
sale for reasons of safety or effectiveness. This determination will
allow FDA to approve abbreviated new drug applications (ANDAs) for
BORTEZOMIB (bortezomib) solution, 2.5 mg/mL and 3.5 mg/1.4 mL (2.5 mg/
mL), if all other legal and regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Donna Tran, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6213, Silver Spring, MD 20993-0002, 301-796-3600,
[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.
BORTEZOMIB (bortezomib) solution, 2.5 mg/mL and 3.5 mg/1.4 mL (2.5
mg/mL), is the subject of NDA 215441, held by Accord Healthcare Inc.,
and initially approved on July 26, 2022. BORTEZOMIB is indicated for
the treatment of adult patients with multiple myeloma or mantle cell
lymphoma.
In a letter dated February 8, 2023, Accord Healthcare Inc. notified
FDA that BORTEZOMIB (bortezomib) solution, 2.5 mg/mL and 3.5 mg/1.4 mL
(2.5 mg/mL), was being discontinued, and FDA moved the drug product to
the ``Discontinued Drug Product List'' section of the Orange Book.
Qilu Pharmaceutical (Hainan) Co., Ltd. submitted a citizen petition
dated April 19, 2023 (Docket No. FDA-2023-P-1549), under 21 CFR 10.30,
requesting that the Agency determine whether BORTEZOMIB (bortezomib)
solution, 2.5 mg/mL and 3.5 mg/1.4 mL (2.5 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 BORTEZOMIB (bortezomib) solution, 2.5 mg/mL
and 3.5 mg/1.4 mL (2.5 mg/mL), was not withdrawn for reasons of safety
or effectiveness. The petitioner has identified no data or other
information suggesting that BORTEZOMIB (bortezomib) solution, 2.5 mg/mL
and 3.5 mg/1.4 mL (2.5 mg/mL), was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of BORTEZOMIB (bortezomib) solution, 2.5 mg/
mL and 3.5 mg/1.4 mL (2.5 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 BORTEZOMIB
(bortezomib) solution, 2.5 mg/mL and 3.5 mg/1.4 mL (2.5 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. ANDAs that refer to these drug products
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 these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.
Dated: August 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17746 Filed 8-17-23; 8:45 am]
BILLING CODE 4164-01-P