Determination That Dihydroergotamine Mesylate 45 Injection USP, 1 Milligram/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 10344 [2023-03381]
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10344
Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices
Dated: February 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–03367 Filed 2–16–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–P–2842]
Determination That Dihydroergotamine
Mesylate 45 Injection USP, 1 Milligram/
Milliliter, Was Not Withdrawn From
Sale for Reasons of Safety or
Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that D.H.E. 45
(dihydroergotamine mesylate) injection
USP, 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was not withdrawn from sale for reasons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:
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,
Donna.Tran@fda.hhs.gov.
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
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:13 Feb 16, 2023
Jkt 259001
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 (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
D.H.E. 45 (dihydroergotamine
mesylate) injection USP, 1 mg/mL, is
the subject of NDA 005929, held by
Bausch Health US, LLC, and initially
approved on April 12, 1946. D.H.E. 45
(dihydroergotamine mesylate) is
indicated for the acute treatment of
migraine headaches with or without
aura and the acute treatment of cluster
headache episodes.
In a letter dated June 13, 2022, Bausch
Health US, LLC notified FDA that
D.H.E. 45 (dihydroergotamine mesylate)
injection USP, 1 mg/mL, was being
discontinued, and FDA moved the drug
product to the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book.
Baxter Healthcare Corporation
submitted a citizen petition dated
November 11, 2022 (Docket No. FDA–
2022–P–2842), under 21 CFR 10.30,
requesting that the Agency determine
whether D.H.E. 45 (dihydroergotamine
mesylate) injection USP, 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
§ 314.161 that D.H.E. 45
(dihydroergotamine mesylate) injection
USP, 1 mg/mL, was not withdrawn for
reasons of safety or effectiveness. The
petitioner has identified no data or other
information suggesting that D.H.E. 45
(dihydroergotamine mesylate) injection
USP, 1 mg/mL, was withdrawn for
reasons of safety or effectiveness. We
have carefully reviewed our files for
records concerning the withdrawal of
D.H.E. 45 (dihydroergotamine mesylate)
injection USP, 1 mg/mL, from sale. We
have also independently evaluated
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
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 D.H.E. 45
(dihydroergotamine mesylate) injection
USP, 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. 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: February 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–03381 Filed 2–16–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–0438]
International Drug Scheduling;
Convention on Psychotropic
Substances; Single Convention on
Narcotic Drugs; World Health
Organization; Scheduling
Recommendations; ADB-BUTINACA;
Alpha-PiHP; 3-Methylmethcathinone;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is providing
interested persons with the opportunity
to submit written comments concerning
recommendations by the World Health
Organization (WHO) to impose
international manufacturing and
distributing restrictions, under
international treaties, on certain drug
substances. The comments received in
response to this notice will be
considered in preparing the United
States’ position on these proposals for a
meeting of the United Nations
SUMMARY:
E:\FR\FM\17FEN1.SGM
17FEN1
]]>Agencies
[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Page 10344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03381]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-2842]
Determination That Dihydroergotamine Mesylate 45 Injection USP, 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 D.H.E. 45 (dihydroergotamine mesylate) injection USP, 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: 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.
D.H.E. 45 (dihydroergotamine mesylate) injection USP, 1 mg/mL, is
the subject of NDA 005929, held by Bausch Health US, LLC, and initially
approved on April 12, 1946. D.H.E. 45 (dihydroergotamine mesylate) is
indicated for the acute treatment of migraine headaches with or without
aura and the acute treatment of cluster headache episodes.
In a letter dated June 13, 2022, Bausch Health US, LLC notified FDA
that D.H.E. 45 (dihydroergotamine mesylate) injection USP, 1 mg/mL, was
being discontinued, and FDA moved the drug product to the
``Discontinued Drug Product List'' section of the Orange Book.
Baxter Healthcare Corporation submitted a citizen petition dated
November 11, 2022 (Docket No. FDA-2022-P-2842), under 21 CFR 10.30,
requesting that the Agency determine whether D.H.E. 45
(dihydroergotamine mesylate) injection USP, 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 D.H.E. 45 (dihydroergotamine mesylate)
injection USP, 1 mg/mL, was not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that D.H.E. 45 (dihydroergotamine mesylate)
injection USP, 1 mg/mL, was withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of D.H.E. 45 (dihydroergotamine mesylate)
injection USP, 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 D.H.E. 45
(dihydroergotamine mesylate) injection USP, 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. 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: February 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-03381 Filed 2-16-23; 8:45 am]
BILLING CODE 4164-01-P
