Notice2021-27699
Determination That ANTIZOL (Fomepizole) Injection, 1.5 Grams/1.5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Primary source
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Published
December 22, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) has determined that ANTIZOL (fomepizole) Injection, 1.5 grams (g)/1.5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness.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 the ANDAs meet relevant legal and regulatory requirements.
Full Text
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<title>Federal Register, Volume 86 Issue 243 (Wednesday, December 22, 2021)</title>
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[Federal Register Volume 86, Number 243 (Wednesday, December 22, 2021)]
[Notices]
[Page 72608]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-27699]
[[Page 72608]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-P-0923]
Determination That ANTIZOL (Fomepizole) Injection, 1.5 Grams/1.5
Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or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 ANTIZOL (fomepizole) Injection, 1.5 grams (g)/1.5
milliliters (mL), was not withdrawn from sale for reasons of safety or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 the
ANDAs 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. 6272, Silver Spring, MD 20993-0002, 240-
825-9944, <a href="/cdn-cgi/l/email-protection#0f446e6a7b606c67662140646a62686d604f696b6e2167677c21686079"><span class="__cf_email__" data-cfemail="a4efc5c1d0cbc7cccd8aebcfc1c9c3c6cbe4c2c0c58accccd78ac3cbd2">[email protected]</span></a>.
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.
ANTIZOL (fomepizole) Injection, 1.5 g/1.5 mL, is the subject of NDA
020696, held by Par Pharmaceuticals Inc., and initially approved on
December 4, 1997. ANTIZOL is indicated as an antidote for ethylene
glycol (such as antifreeze) or methanol poisoning, or for use in
suspected ethylene glycol or methanol ingestion, either alone or in
combination with hemodialysis. ANTIZOL (fomepizole) Injection, 1.5 g/
1.5 mL is currently listed in the ``Discontinued Drug Product List''
section of the Orange Book.
Gland Pharma Ltd. submitted a citizen petition dated August 19,
2021 (Docket No. FDA-2021-P-0923), under 21 CFR 10.30, requesting that
the Agency determine whether ANTIZOL (fomepizole) Injection, 1.5 g/1.5
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 ANTIZOL (fomepizole) Injection, 1.5 g/1.5 mL,
was not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
ANTIZOL (fomepizole) Injection, 1.5 g/1.5 mL, was withdrawn for reasons
of safety or effectiveness. We have carefully reviewed our files for
records concerning the withdrawal of ANTIZOL (fomepizole) Injection,
1.5 g/1.5 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 ANTIZOL (fomepizole)
Injection, 1.5 g/1.5 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. 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: December 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-27699 Filed 12-21-21; 8:45 am]
BILLING CODE 4164-01-P
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