Determination That NORFLEX (Orphenadrine Citrate) Injection, 30 Milligrams/Milliliter, and NORFLEX (Orphenadrine Citrate) Extended-Release Tablet, 100 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 75278-75279 [2022-26663]
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75278
Federal Register / Vol. 87, No. 235 / Thursday, December 8, 2022 / Notices
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 9,
2023. Approval of each entire
application is withdrawn, including any
strengths and dosage forms included in
the application but inadvertently
missing from the table. Introduction or
delivery for introduction into interstate
commerce of products without
approved new drug applications
violates section 301(a) and (d) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 331(a) and (d)). Drug
products that are listed in the table that
are in inventory on January 9, 2023 may
continue to be dispensed until the
inventories have been depleted or the
drug products have reached their
expiration dates or otherwise become
violative, whichever occurs first.
Dated: December 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–26661 Filed 12–7–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–P–0585]
Determination That NORFLEX
(Orphenadrine Citrate) Injection, 30
Milligrams/Milliliter, and NORFLEX
(Orphenadrine Citrate) ExtendedRelease Tablet, 100 Milligrams, Were
Not Withdrawn From Sale for Reasons
of Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we)
has determined that NORFLEX
(orphenadrine citrate) Injection, 30
milligrams (mg)/milliliter (mL), and
NORFLEX (orphenadrine citrate)
Extended-Release Tablet, 100 mg, were
not withdrawn from sale for reasons of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:
Anuj Shah, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:36 Dec 07, 2022
Jkt 259001
Ave., Bldg. 51, Rm. 6224, Silver Spring,
MD 20993–0002, 301–796–2246,
Anuj.Shah@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
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
FDA’s approval of 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.
NORFLEX (orphenadrine citrate)
Injection, 30 mg/mL, is the subject of
NDA 013055, held by Pai Holdings LLC
DBA Pharmaceutical Associates Inc.,
and initially approved on October 2,
1960. NORFLEX (orphenadrine citrate)
Extended-Release Tablet, 100 mg, is the
subject of NDA 012157, held by Bausch
Health US LLC, and initially approved
on November 2, 1959. Both NORFLEX
drug products are indicated as an
adjunct to rest, physical therapy, and
other measures for the relief of
discomfort associated with acute painful
musculoskeletal conditions.
Both NORFLEX (orphenadrine citrate)
Injection, 30 mg/mL, and NORFLEX
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
(orphenadrine citrate) Extended-Release
Tablet, 100 mg, are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Odin Pharmaceuticals, LLC,
submitted a citizen petition dated April
11, 2022 (Docket No. FDA–2022–P–
0585), under 21 CFR 10.30, requesting
that the Agency determine whether
NORFLEX (orphenadrine citrate)
Injection, 30 mg/mL, was withdrawn
from sale for reasons of safety or
effectiveness. Although the citizen
petition did not address the 100 mg
extended-release tablet, that dosage
form and strength has also been
discontinued. On our own initiative, we
have also determined whether that
dosage form and strength was
withdrawn for safety or effectiveness
reasons.
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 NORFLEX (orphenadrine
citrate) Injection, 30 mg/mL, and
NORFLEX (orphenadrine citrate)
Extended-Release Tablet, 100 mg, were
not withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that these drug products
were withdrawn for reasons of safety or
effectiveness. We have carefully
reviewed our files for records
concerning the withdrawal of NORFLEX
(orphenadrine citrate) Injection, 30 mg/
mL, and NORFLEX (orphenadrine
citrate) Extended-Release Tablet, 100
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 these drug products were
withdrawn from sale for reasons of
safety or effectiveness.
Accordingly, the Agency will
continue to list NORFLEX
(orphenadrine citrate) Injection, 30 mg/
mL, and NORFLEX (orphenadrine
citrate) Extended-Release Tablet, 100
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. 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
E:\FR\FM\08DEN1.SGM
08DEN1
Federal Register / Vol. 87, No. 235 / Thursday, December 8, 2022 / Notices
current standards, the Agency will
advise ANDA applicants to submit such
labeling.
Dated: December 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–26663 Filed 12–7–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08N146B,
Rockville, Maryland 20857; (301) 443–
6593, or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the United States Court of Federal
Claims and to serve a copy of the
petition to the Secretary of HHS, who is
named as the respondent in each
proceeding. The Secretary has delegated
this responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
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Jkt 259001
appropriate, and make initial decisions
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
October 1, 2022, through October 31,
2022. This list provides the name of
petitioner, city and state of vaccination
(if unknown then city and state of
person or attorney filing claim), and
case number. In cases where the Court
has redacted the name of a petitioner
and/or the case number, the list reflects
such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
evidence that the illness, disability,
injury, condition, or death described in
the petition is due to factors unrelated
to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
a. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition not set forth in the
Vaccine Injury Table but which was
caused by’’ one of the vaccines referred
to in the Table, or
b. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition set forth in the
Vaccine Injury Table the first symptom
or manifestation of the onset or
significant aggravation of which did not
occur within the time period set forth in
the Table but which was caused by a
vaccine’’ referred to in the Table.
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Fmt 4703
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75279
In accordance with section 2112(b)(2),
all interested persons may submit
written information relevant to the
issues described above in the case of the
petitions listed below. Any person
choosing to do so should file an original
and three (3) copies of the information
with the Clerk of the United States
Court of Federal Claims at the address
listed above (under the heading FOR
FURTHER INFORMATION CONTACT), with a
copy to HRSA addressed to Director,
Division of Injury Compensation
Programs, Health Systems Bureau, 5600
Fishers Lane, 08N146B, Rockville,
Maryland 20857. The Court’s caption
(Petitioner’s Name v. Secretary of HHS)
and the docket number assigned to the
petition should be used as the caption
for the written submission. Chapter 35
of title 44, United States Code, related
to paperwork reduction, does not apply
to information required for purposes of
carrying out the Program.
Carole Johnson,
Administrator.
List of Petitions Filed
1. Thomas Mayo, Wauwatosa, Wisconsin,
Court of Federal Claims No: 22–1421V
2. Marsha Pavlik Wood, Stow, Ohio, Court of
Federal Claims No: 22–1422V
3. Ella Burroughs, Phoenix, Arizona, Court of
Federal Claims No: 22–1423V
4. Sylvia Kline on behalf of B.H., Phoenix,
Arizona, Court of Federal Claims No: 22–
1424V
5. Ross Kleiman, Boston, Massachusetts,
Court of Federal Claims No: 22–1426V
6. Lindsey Alvarez, Fullerton, California,
Court of Federal Claims No: 22–1428V
7. Deanna A. Finch, Newport, Tennessee,
Court of Federal Claims No: 22–1429V
8. Larry Pierce, Kansas City, Kansas, Court of
Federal Claims No: 22–1432V
9. Joann Bauer, Duluth, Minnesota, Court of
Federal Claims No: 22–1440V
10. Arthur Passarelli, Washington, District of
Columbia, Court of Federal Claims No:
22–1443V
11. James Thurston and Valerie Thurston on
behalf of A.T., Lakeland, Florida, Court
of Federal Claims No: 22–1444V
12. Andrea Cuatt, Los Angeles, California,
Court of Federal Claims No: 22–1447V
13. Judith Wertin, Fort Bragg, California,
Court of Federal Claims No: 22–1449V
14. Grace Laurin, Plattsburgh, New York,
Court of Federal Claims No: 22–1450V
15. Stacey R. Williams, Fort Bragg, North
Carolina, Court of Federal Claims No:
22–1451V
16. Juliet Hawk, San Diego, California, Court
of Federal Claims No: 22–1454V
17. Kenneth Ingalsbe, Batavia, New York,
Court of Federal Claims No: 22–1457V
18. Meaghan Clifford, Boston, Massachusetts,
Court of Federal Claims No: 22–1458V
19. Karessa Hinson-Sherwood, Gainesville,
Florida, Court of Federal Claims No: 22–
1461V
20. Tiffany Wentworth, Simsbury,
E:\FR\FM\08DEN1.SGM
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]]>Agencies
[Federal Register Volume 87, Number 235 (Thursday, December 8, 2022)]
[Notices]
[Pages 75278-75279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-26663]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-P-0585]
Determination That NORFLEX (Orphenadrine Citrate) Injection, 30
Milligrams/Milliliter, and NORFLEX (Orphenadrine Citrate) Extended-
Release Tablet, 100 Milligrams, Were 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, Agency, or we) has
determined that NORFLEX (orphenadrine citrate) Injection, 30 milligrams
(mg)/milliliter (mL), and NORFLEX (orphenadrine citrate) Extended-
Release Tablet, 100 mg, were 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: Anuj Shah, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6224, Silver Spring, MD 20993-0002, 301-796-2246,
[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 FDA's approval of 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.
NORFLEX (orphenadrine citrate) Injection, 30 mg/mL, is the subject
of NDA 013055, held by Pai Holdings LLC DBA Pharmaceutical Associates
Inc., and initially approved on October 2, 1960. NORFLEX (orphenadrine
citrate) Extended-Release Tablet, 100 mg, is the subject of NDA 012157,
held by Bausch Health US LLC, and initially approved on November 2,
1959. Both NORFLEX drug products are indicated as an adjunct to rest,
physical therapy, and other measures for the relief of discomfort
associated with acute painful musculoskeletal conditions.
Both NORFLEX (orphenadrine citrate) Injection, 30 mg/mL, and
NORFLEX (orphenadrine citrate) Extended-Release Tablet, 100 mg, are
currently listed in the ``Discontinued Drug Product List'' section of
the Orange Book.
Odin Pharmaceuticals, LLC, submitted a citizen petition dated April
11, 2022 (Docket No. FDA-2022-P-0585), under 21 CFR 10.30, requesting
that the Agency determine whether NORFLEX (orphenadrine citrate)
Injection, 30 mg/mL, was withdrawn from sale for reasons of safety or
effectiveness. Although the citizen petition did not address the 100 mg
extended-release tablet, that dosage form and strength has also been
discontinued. On our own initiative, we have also determined whether
that dosage form and strength was withdrawn for safety or effectiveness
reasons.
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 NORFLEX (orphenadrine citrate) Injection, 30
mg/mL, and NORFLEX (orphenadrine citrate) Extended-Release Tablet, 100
mg, were not withdrawn for reasons of safety or effectiveness. The
petitioner has identified no data or other information suggesting that
these drug products were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of NORFLEX (orphenadrine citrate) Injection,
30 mg/mL, and NORFLEX (orphenadrine citrate) Extended-Release Tablet,
100 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 these drug products were
withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the Agency will continue to list NORFLEX (orphenadrine
citrate) Injection, 30 mg/mL, and NORFLEX (orphenadrine citrate)
Extended-Release Tablet, 100 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. 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
[[Page 75279]]
current standards, the Agency will advise ANDA applicants to submit
such labeling.
Dated: December 5, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-26663 Filed 12-7-22; 8:45 am]
BILLING CODE 4164-01-P
