Determination That CATAPRES (Clonidine Hydrochloride) Tablets, 0.1 Milligrams; 0.2 Milligrams; and 0.3 Milligrams, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 30989-30990 [2023-10296]
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30989
Federal Register / Vol. 88, No. 93 / Monday, May 15, 2023 / Notices
marketing or use of the product.
Thereafter, the USPTO requested that
FDA determine the product’s regulatory
review period.
ddrumheller on DSK120RN23PROD with NOTICES1
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
Tack Endovascular System (6F) is 1,338
days. Of this time, 1,114 days occurred
during the testing phase of the
regulatory review period, while 224
days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date an exemption for this
device, under section 520(g) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 360j(g)), became
effective: August 14, 2015. FDA has
verified the applicant’s claim that the
date the investigational device
exemption (IDE) for human tests to
begin, as required under section 520(g)
of the FD&C Act, became effective
August 14, 2015.
2. The date an application was
initially submitted with respect to the
device under section 515 of the FD&C
Act (21 U.S.C. 360e): August 31, 2018.
FDA has verified the applicant’s claim
that the premarket approval application
(PMA) for Tack Endovascular System
(6F) (PMA P180034) was initially
submitted August 31, 2018.
3. The date the application was
approved: April 11, 2019. FDA has
verified the applicant’s claim that PMA
P180034 was approved on April 11,
2019.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its applications for patent extension,
this applicant seeks 485 days or 621
days of patent term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
Application No.
Drug name
NDA 017407 ....
NDA 017534 ....
CATAPRES ...................
FIORINAL ......................
VerDate Sep<11>2014
19:07 May 12, 2023
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: May 10, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–10297 Filed 5–12–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1703]
Determination That CATAPRES
(Clonidine Hydrochloride) Tablets, 0.1
Milligrams; 0.2 Milligrams; and 0.3
Milligrams, and Other Drug Products
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 or Agency) has
determined that the drug products listed
in this document 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
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to the products as long as they
meet relevant legal and regulatory
requirements.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug
Active ingredient(s)
Clonidine Hydrochloride
Aspirin; Butalbital; Caffeine.
Jkt 259001
PO 00000
Frm 00047
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6236, Silver Spring,
MD 20993–0002, 301–796–8363,
Stacy.Kane@fda.hhs.gov.
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 generally known
as the ‘‘Orange Book.’’ Under FDA
regulations, a drug is 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).
Under § 314.161(a) (21 CFR
314.161(a)), the Agency must determine
whether a listed drug was withdrawn
from sale for reasons of safety or
effectiveness: (1) before an ANDA that
refers to that listed drug may be
approved, (2) whenever a listed drug is
voluntarily withdrawn from sale and
ANDAs that refer to the listed drug have
been approved, and (3) when a person
petitions for such a determination under
21 CFR 10.25(a) and 10.30. Section
314.161(d) provides that if FDA
determines that a listed drug was
withdrawn from sale for safety or
effectiveness reasons, the Agency will
initiate proceedings that could result in
the withdrawal of approval of the
ANDAs that refer to the listed drug.
FDA has become aware that the drug
products listed in the table are no longer
being marketed.
SUPPLEMENTARY INFORMATION:
Strength(s)
Dosage form/route
0.1 Milligrams (mg); 0.2 mg; 0.3 mg
325 mg; 50 mg; 40 mg ......................
Tablet; Oral ....................
Capsule; Oral .................
Fmt 4703
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E:\FR\FM\15MYN1.SGM
15MYN1
Applicant
Boehringer Ingelheim.
Allergan Sales.
30990
Federal Register / Vol. 88, No. 93 / Monday, May 15, 2023 / Notices
Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
NDA 017876 ....
LOESTRIN 21 1/20 .......
0.02 mg; 1 mg ...................................
Tablet; Oral ....................
Teva Branded Pharms.
NDA 018647 ....
CORZIDE .......................
5 mg; 40 mg; 5 mg; 80 mg ................
Tablet; Oral ....................
King Pharms., LLC.
NDA 018685 ....
GAVISCON ....................
80 mg; 20 mg; 160 mg, 40 mg ..........
Tablet; Oral ....................
Chattem.
NDA 018751 ....
NDA 019813 ....
SPECTAZOLE ...............
DURAGESIC–100 .........
Ethinyl Estradiol;
Norethindrone Acetate.
Bendroflumethiazide;
Nadolol.
Aluminum Hydroxide;
Magnesium Trisilicate.
Econazole Nitrate ..........
Fentanyl .........................
Cream; Topical ..............
Film, Extended Release;
Transdermal.
Alvogen, Inc.
Janssen Pharms.
NDA 020519 ....
NDA 021015 ....
CICLOPIROX .................
ANDROGEL ...................
Ciclopirox .......................
Testosterone ..................
Gel; Topical ...................
Gel; Transdermal ...........
Alvogen, Inc.
Besins Healthcare.
NDA 021152 ....
NDA 021169 ....
CUTIVATE .....................
RAZADYNE ...................
Lotion; Topical ...............
Tablet; Oral ....................
Fougera Pharms.
Janssen Pharms.
NDA 021567 ....
NDA 021695 ....
Capsule; Oral .................
Capsule; Oral .................
Bristol Myers Squibb.
Lupin.
NDA 022107 ....
REYATAZ ......................
ANTARA
(MICRONIZED).
TEKTURNA HCT ...........
Fluticasone Propionate ..
Galantamine
Hydrobromide.
Atazanavir Sulfate .........
Fenofibrate .....................
1% ......................................................
100 Micrograms (mcg)/Hour; 12.5
mcg/Hour; 25 mcg/Hour; 37.5 mcg/
Hour; 50 mcg/Hour; 75 mcg/Hour.
0.77% .................................................
25 mg/2.5 Grams (g) Packet; 50 mg/
5 g Packet.
0.05% .................................................
Equivalent to (EQ) 4 mg Base; EQ 8
mg Base; EQ 12 mg Base.
EQ 150 mg Base ...............................
30 mg .................................................
Tablet; Oral ....................
Noden Pharma.
NDA 022309 ....
ANDROGEL ...................
Testosterone ..................
Gel; Transdermal ...........
Besins Healthcare.
NDA 022401 ....
TWYNSTA .....................
Amlodipine Besylate;
Telmisartan.
Tablet; Oral ....................
Boehringer Ingelheim.
NDA 022426 ....
OSENI ............................
Tablet; Oral ....................
Takeda Pharms. USA.
NDA 050824 ....
OMEPRAZOLE AND
CLARITHROMYCIN
AND AMOXICILLIN.
Alogliptin Benzoate;
Pioglitazone Hydrochloride.
Amoxicillin;
Clarithromycin;
Omeprazole.
EQ 150 mg Base; 12.5 mg; EQ 150
mg Base; 25 mg; 300 mg; 12.5
mg; 300 mg; 25 mg.
1.62% (20.25 mg/1.25 g Packet);
1.62% (40.5 mg/2.5 g Packet).
EQ 5 mg Base; 40 mg; EQ 10 mg
Base; 40 mg; EQ 5 mg Base; 80
mg; EQ 10 mg Base; 80 mg.
EQ 12.5 mg Base; EQ 15 mg Base;
EQ 12.5 mg Base; EQ 45 mg Base.
500 mg, n/a, n/a; n/a, 500 mg, n/a; n/
a, n/a, 20 mg.
Capsule, Tablet, Capsule, Delayed Release; Oral.
Cumberland Pharms.
Aliskiren Hemifumarate;
Hydrochlorothiazide.
ddrumheller on DSK120RN23PROD with NOTICES1
FDA has reviewed its records and,
under § 314.161, has determined that
the drug products listed were not
withdrawn from sale for reasons of
safety or effectiveness. Accordingly, the
Agency will continue to list the drug
products in the ‘‘Discontinued Drug
Product List’’ section of the Orange
Book. The ‘‘Discontinued Drug Product
List’’ identifies, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness.
Approved ANDAs that refer to the
drug products listed are unaffected by
the discontinued marketing of the
products subject to these applications.
Additional ANDAs that refer to these
products may also be approved by the
Agency if they comply with relevant
legal and regulatory requirements. 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: May 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–10296 Filed 5–12–23; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:07 May 12, 2023
Jkt 259001
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–
SUMMARY:
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
Applicant
6593, or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
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
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
SUPPLEMENTARY INFORMATION:
E:\FR\FM\15MYN1.SGM
15MYN1
]]>Agencies
[Federal Register Volume 88, Number 93 (Monday, May 15, 2023)]
[Notices]
[Pages 30989-30990]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-10296]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1703]
Determination That CATAPRES (Clonidine Hydrochloride) Tablets,
0.1 Milligrams; 0.2 Milligrams; and 0.3 Milligrams, and Other Drug
Products 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 or Agency) has
determined that the drug products listed in this document 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
these drug products, and it will allow FDA to continue to approve ANDAs
that refer to the products as long as they meet relevant legal and
regulatory requirements.
FOR FURTHER INFORMATION CONTACT: Stacy Kane, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6236, Silver Spring, MD 20993-0002, 301-796-8363,
[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
generally known as the ``Orange Book.'' Under FDA regulations, a drug
is 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).
Under Sec. 314.161(a) (21 CFR 314.161(a)), the Agency must
determine whether a listed drug was withdrawn from sale for reasons of
safety or effectiveness: (1) before an ANDA that refers to that listed
drug may be approved, (2) whenever a listed drug is voluntarily
withdrawn from sale and ANDAs that refer to the listed drug have been
approved, and (3) when a person petitions for such a determination
under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if
FDA determines that a listed drug was withdrawn from sale for safety or
effectiveness reasons, the Agency will initiate proceedings that could
result in the withdrawal of approval of the ANDAs that refer to the
listed drug.
FDA has become aware that the drug products listed in the table are
no longer being marketed.
----------------------------------------------------------------------------------------------------------------
Active
Application No. Drug name ingredient(s) Strength(s) Dosage form/route Applicant
----------------------------------------------------------------------------------------------------------------
NDA 017407........ CATAPRES......... Clonidine 0.1 Milligrams Tablet; Oral..... Boehringer
Hydrochloride. (mg); 0.2 mg; Ingelheim.
0.3 mg.
NDA 017534........ FIORINAL......... Aspirin; 325 mg; 50 mg; 40 Capsule; Oral.... Allergan Sales.
Butalbital; mg.
Caffeine.
[[Page 30990]]
NDA 017876........ LOESTRIN 21 1/20. Ethinyl 0.02 mg; 1 mg.... Tablet; Oral..... Teva Branded
Estradiol; Pharms.
Norethindrone
Acetate.
NDA 018647........ CORZIDE.......... Bendroflumethiazi 5 mg; 40 mg; 5 Tablet; Oral..... King Pharms.,
de; Nadolol. mg; 80 mg. LLC.
NDA 018685........ GAVISCON......... Aluminum 80 mg; 20 mg; 160 Tablet; Oral..... Chattem.
Hydroxide; mg, 40 mg.
Magnesium
Trisilicate.
NDA 018751........ SPECTAZOLE....... Econazole Nitrate 1%............... Cream; Topical... Alvogen, Inc.
NDA 019813........ DURAGESIC-100.... Fentanyl......... 100 Micrograms Film, Extended Janssen Pharms.
(mcg)/Hour; 12.5 Release;
mcg/Hour; 25 mcg/ Transdermal.
Hour; 37.5 mcg/
Hour; 50 mcg/
Hour; 75 mcg/
Hour.
NDA 020519........ CICLOPIROX....... Ciclopirox....... 0.77%............ Gel; Topical..... Alvogen, Inc.
NDA 021015........ ANDROGEL......... Testosterone..... 25 mg/2.5 Grams Gel; Transdermal. Besins
(g) Packet; 50 Healthcare.
mg/5 g Packet.
NDA 021152........ CUTIVATE......... Fluticasone 0.05%............ Lotion; Topical.. Fougera Pharms.
Propionate.
NDA 021169........ RAZADYNE......... Galantamine Equivalent to Tablet; Oral..... Janssen Pharms.
Hydrobromide. (EQ) 4 mg Base;
EQ 8 mg Base; EQ
12 mg Base.
NDA 021567........ REYATAZ.......... Atazanavir EQ 150 mg Base... Capsule; Oral.... Bristol Myers
Sulfate. Squibb.
NDA 021695........ ANTARA Fenofibrate...... 30 mg............ Capsule; Oral.... Lupin.
(MICRONIZED).
NDA 022107........ TEKTURNA HCT..... Aliskiren EQ 150 mg Base; Tablet; Oral..... Noden Pharma.
Hemifumarate; 12.5 mg; EQ 150
Hydrochlorothiaz mg Base; 25 mg;
ide. 300 mg; 12.5 mg;
300 mg; 25 mg.
NDA 022309........ ANDROGEL......... Testosterone..... 1.62% (20.25 mg/ Gel; Transdermal. Besins
1.25 g Packet); Healthcare.
1.62% (40.5 mg/
2.5 g Packet).
NDA 022401........ TWYNSTA.......... Amlodipine EQ 5 mg Base; 40 Tablet; Oral..... Boehringer
Besylate; mg; EQ 10 mg Ingelheim.
Telmisartan. Base; 40 mg; EQ
5 mg Base; 80
mg; EQ 10 mg
Base; 80 mg.
NDA 022426........ OSENI............ Alogliptin EQ 12.5 mg Base; Tablet; Oral..... Takeda Pharms.
Benzoate; EQ 15 mg Base; USA.
Pioglitazone EQ 12.5 mg Base;
Hydrochloride. EQ 45 mg Base.
NDA 050824........ OMEPRAZOLE AND Amoxicillin; 500 mg, n/a, n/a; Capsule, Tablet, Cumberland
CLARITHROMYCIN Clarithromycin; n/a, 500 mg, n/ Capsule, Delayed Pharms.
AND AMOXICILLIN. Omeprazole. a; n/a, n/a, 20 Release; Oral.
mg.
----------------------------------------------------------------------------------------------------------------
FDA has reviewed its records and, under Sec. 314.161, has
determined that the drug products listed were not withdrawn from sale
for reasons of safety or effectiveness. Accordingly, the Agency will
continue to list the drug products in the ``Discontinued Drug Product
List'' section of the Orange Book. The ``Discontinued Drug Product
List'' identifies, among other items, drug products that have been
discontinued from marketing for reasons other than safety or
effectiveness.
Approved ANDAs that refer to the drug products listed are
unaffected by the discontinued marketing of the products subject to
these applications. Additional ANDAs that refer to these products may
also be approved by the Agency if they comply with relevant legal and
regulatory requirements. 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: May 9, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-10296 Filed 5-12-23; 8:45 am]
BILLING CODE 4164-01-P
