Determination That AVC (Sulfanilamide) Vaginal Cream, 15%, and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness, 48484-48486 [2022-17056]
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48484
Federal Register / Vol. 87, No. 152 / Tuesday, August 9, 2022 / Notices
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: ORR reimburses, to the
extent of available appropriations,
certain non-federal costs for the
provision of cash and medical
assistance (CMA) to refugees, along with
allowable expenses for the
administration of the refugee
resettlement program at the state level.
States and Replacement Designees
currently submit the ORR–2 Quarterly
Report on Expenditures and
Obligations, which provides aggregate
expenditure and obligation data. The
ORR–2 collects expenditures and
obligations data separately for each of
the four following CMA program
components: refugee cash assistance,
refugee medical assistance, CMA
administration, and services for
unaccompanied minors. This
breakdown of financial status data
allows ORR to track program
expenditures in greater detail to
anticipate any funding issues and to
meet the requirements of ORR
regulations at CFR 400.211 to collect
these data for use in estimating future
costs of the refugee resettlement
program. ORR must implement the
methodology at CFR 400.211 each year
after receipt of its annual appropriation
to ensure that appropriated funds will
be adequate for reimbursement to states
of the costs for assistance provided to
entering refugees. The estimating
methodology prescribed in the
regulations requires the use of actual
past costs by program component. If the
methodology indicates that
appropriated funds are inadequate, ORR
must take steps to reduce federal
expenses, such as by limiting the
number of months of eligibility for
Refugee Cash Assistance and Refugee
Medical Assistance. The ORR–2 is a
single-page financial report that allows
ORR to collect the necessary data to
ensure that funds are adequate for the
projected need and thereby meet the
requirements of both the Refugee Act
and ORR regulations.
Respondents: State governments and
Replacement Designees.
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Total
number of
responses per
respondent
Average
burden hours
per response
Annual burden
hours
63
4
1.5
378
ORR–2, Cash and Medical Assistance Program, Quarterly Report on Expenditures and Obligations ..........................................................................
Estimated Total Annual Burden
Hours: 378.
Authority: 8 U.S.C. 1522 Sec. 412 and
8 U.S.C. 524 (Title IV), Sec. 414.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2022–17078 Filed 8–8–22; 8:45 am]
BILLING CODE 4184–45–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–N–1694]
Determination That AVC
(Sulfanilamide) Vaginal Cream, 15%,
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
jspears on DSK121TN23PROD with NOTICES
SUMMARY:
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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,
Stacy.Kane@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
PO 00000
Frm 00034
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\09AUN1.SGM
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Federal Register / Vol. 87, No. 152 / Tuesday, August 9, 2022 / Notices
Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
.....
.....
.....
.....
.....
.....
AVC ...................................
SELSUN ............................
XYLOCAINE ......................
COUMADIN .......................
CORDRAN SP ...................
QUINAGLUTE ...................
Sulfanilamide .....................
Selenium Sulfide ................
Lidocaine Hydrochloride ....
Warfarin Sodium ................
Flurandrenolide ..................
Quinidine Gluconate ..........
15% ....................................
2.5% ...................................
2% ......................................
1 Milligram (mg) .................
0.025% ...............................
324 mg ...............................
NDA 017386 .....
NDA 017531 .....
ZAROXOLYN .....................
TIGAN ................................
2.5 mg; 5 mg; 10 mg .........
300 mg ...............................
Lannett Co., Inc.
King Pharms LLC.
NDA 018081 .....
NDA 018281 .....
NDA 018303 .....
DEPAKENE .......................
TEGRETOL .......................
LOPRESSOR HCT ............
250 mg ...............................
100 mg ...............................
25mg; 100mg .....................
Capsule; Oral .....................
Tablet, Chewable; Oral ......
Tablet; Oral ........................
AbbVie Inc.
Novartis.
Validus Pharms.
NDA
NDA
NDA
NDA
.....
.....
.....
.....
INDOCIN ............................
OCUFEN ............................
CYTOVENE .......................
ORTHO TRI–CYCLEN ......
Metolazone ........................
Trimethobenzamide Hydrochloride.
Valproic Acid ......................
Carbamazepine .................
Hydrochlorothiazide;
Metoprolol Tartrate.
Indomethacin Sodium ........
Flurbiprofen Sodium ..........
Ganciclovir Sodium ............
Ethinyl Estradiol;
Norgestimate.
Cream; Vaginal ..................
Lotion/Shampoo; Topical ...
Jelly; Topical ......................
Tablet; Oral ........................
Cream; Topical ..................
Tablet, Extended Release;
Oral.
Tablet; Oral ........................
Capsule; Oral .....................
Injectable; Injection ............
Solution/Drops; Ophthalmic
Injectable; Injection ............
Tablet; Oral ........................
Recordati Rare Diseases.
Allergan.
Cheplapharm.
Janssen Pharms.
NDA 019766 .....
NDA 019814 .....
NDA 019856 .....
ZOCOR ..............................
BETAGAN ..........................
SINEMET CR ....................
Simvastatin ........................
Levobunolol Hydrochloride
Carbidopa; Levodopa ........
OPTIPRANOLOL ...............
ULTRAVATE ......................
LOTRISONE ......................
NDA 020381 .....
NIASPAN ...........................
Metipranolol Hydrochloride
Halobetasol Propionate .....
Betamethasone
Dipropionate;
Clotrimazole.
Niacin .................................
Tablet; Oral ........................
Solution/Drops; Ophthalmic
Tablet, Extended Release;
Oral.
Solution/Drops; Ophthalmic
Ointment; Topical ..............
Lotion; Topical ...................
Organon.
Allergan.
Organon.
NDA 019907 .....
NDA 019968 .....
NDA 020010 .....
EQ 1 mg Base/Vial ............
0.03% .................................
EQ 500 mg Base/Vial ........
0.035 mg, 0.035 mg, 0.035
mg; 0.18 mg, 0.215 mg,
0.25 mg.
80 mg .................................
0.25% .................................
25 mg, 100 mg; 50 mg,
200 mg.
0.3% ...................................
0.05% .................................
EQ 0.05% Base; 1% .........
NDA 020412 .....
ZERIT ................................
Stavudine ...........................
NDA 020509 .....
GEMZAR ...........................
Gemcitabine Hydrochloride
NDA
NDA
NDA
NDA
NDA
NDA
DEPACON .........................
DURACLON .......................
INTEGRILIN .......................
SOLARAZE ........................
AVELOX ............................
VIDEX EC ..........................
Valproate Sodium ..............
Clonidine Hydrochloride ....
Eptifibatide .........................
Diclofenac Sodium .............
Moxifloxacin Hydrochloride
Didanosine .........................
NDA 021241 .....
ORTHO TRI–CYCLEN LO
Ethinyl Estradiol;
Norgestimate.
NDA 021300 .....
NDA 021312 .....
CLARINEX .........................
CLARINEX .........................
Desloratadine .....................
Desloratadine .....................
NDA 021372 .....
ALOXI ................................
Palonosetron Hydrochloride.
NDA 021444 .....
RISPERDAL ......................
Risperidone ........................
NDA 021455 .....
NDA 021605 .....
BONIVA .............................
CLARINEX D 24 HOUR ....
NDA 021858 .....
NDA 021860 .....
BONIVA .............................
SARAFEM .........................
NDA 021956 .....
DUTOPROL .......................
NDA 022064 .....
XYZAL ...............................
NDA 022106 .....
DORIBAX ...........................
Ibandronate Sodium ..........
Desloratadine;
Pseudoephedrine Sulfate.
Ibandronate Sodium .......... EQ 3 mg Base/3 mL ..........
Fluoxetine Hydrochloride ... EQ 10 mg Base; EQ 20
mg Base.
Hydrochlorothiazide;
12.5 mg; EQ 25 mg TarMetoprolol Succinate.
trate; 12.5 mg: EQ 50
mg Tartrate; 12.5 mg;
EQ 100 mg Tartrate.
Levocetirizine
5 mg ...................................
Dihydrochloride.
Doripenem ......................... 250 mg/Vial; 500 mg/Vial ..
NDA 022129 .....
NDA 022157 .....
ULESFIA ............................
XYZAL ...............................
NDA 022321 .....
EMBEDA ............................
NDA 050261 .....
DECLOMYCIN ...................
NDA 050405 .....
KEFLEX .............................
NDA 050529 .....
PEDIAZOLE .......................
jspears on DSK121TN23PROD with NOTICES
NDA
NDA
NDA
NDA
NDA
NDA
006530
007936
008816
009218
012806
016647
018878
019404
019661
019697
020593
020615
020718
021005
021085
021183
.....
.....
.....
.....
.....
.....
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500 mg; 750 mg; 1g ..........
15 mg; 20 mg; 30 mg; 40
mg.
EQ 200 mg Base/Vial; 1
Gram (g) Base/Vial.
100 mg Base/Milliliter (mL)
5 mg/10 mL (0.5 mg/mL) ...
2 mg/mL; 75 mg/100 mL ...
3% ......................................
EQ 400 mg Base ...............
125 mg; 200 mg; 250 mg;
400 mg.
0.025 mg, 0.025 mg, 0.025
mg; 0.18 mg, 0.215 mg,
0.25 mg.
0.5 mg/mL ..........................
2.5 mg; 5 mg .....................
EQ 0.25 mg Base/5 mL
(EQ 0.05 mg Base/mL);
EQ 0.075 mg Base/1.5
mL (EQ 0.05 mg Base/
mL).
0.5 mg; 1 mg; 2 mg; 3 mg;
4 mg.
EQ 150 mg Base ...............
5 mg; 240 mg ....................
Benzyl Alcohol ................... 5% ......................................
Levocetirizine
2.5 mg/5 mL ......................
Dihydrochloride.
Morphine Sulfate;
20 mg, 0.8 mg; 30 mg, 1.2
Naltrexone Hydrochloride.
mg; 50 mg, 2 mg; 60
mg, 2.4 mg; 80 mg, 3.2
mg; 100 mg, 4 mg.
Demeclocycline Hydro75 mg; 150 mg; 300 mg ....
chloride.
Cephalexin ......................... EQ 250 mg Base; EQ 500
mg Base; EQ 750 mg
Base.
Erythromycin
EQ 200 mg Base/5 mL;
Ethylsuccinate;
EQ 600 mg Base/5 mL.
Sulfisoxazole Acetyl.
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
Applicant
Mylan Specialty LP.
Chattem, Inc.
Akorn.
Bristol Myers Squibb.
Almirall.
Bayer Healthcare.
Bausch and Lomb.
Sun Pharm Inds. Inc.
Merck Sharp Dohme.
Tablet, Extended Release;
Oral.
Capsule; Oral .....................
Bristol Myers Squibb.
Injectable; Injection ............
Lilly.
Injectable; Injection ............
Injectable; Injection ............
Injectable; Injection ............
Gel; Topical .......................
Tablet; Oral ........................
Capsule, Delayed Release
Pellets; Oral.
Tablet; Oral-28 ...................
AbbVie Inc.
Mylan Institutional.
Merck Sharp Dohme.
Fougera Pharms.
Bayer Healthcare.
Bristol Myers Squibb.
Solution; Oral .....................
Tablet, Orally Disintegrating; Oral.
Injectable; Intravenous ......
Tablet, Orally Disintegrating; Oral.
Tablet; Oral ........................
Tablet, Extended Release;
Oral.
Injectable; Intravenous ......
Tablet; Oral ........................
AbbVie Inc.
Janssen Pharms.
Merck Sharp Dohme.
Organon.
Helsinn Healthcare.
Janssen Pharms.
Hoffmann La Roche.
Organon.
Hoffmann La Roche.
Allergan.
Tablet, Extended Release;
Oral.
Concordia.
Tablet; Oral ........................
Chattem Sanofi.
Injectable; Intravenous Infusion.
Lotion; Topical ...................
Solution; Oral .....................
Shionogi, Inc.
Shionogi, Inc.
Chattem Sanofi.
Capsule, Extended Release; Oral.
Alpharma Pharms.
Tablet; Oral ........................
Corepharma.
Capsule; Oral .....................
Pragma.
Granule; Oral .....................
Ross Labs.
E:\FR\FM\09AUN1.SGM
09AUN1
48486
Federal Register / Vol. 87, No. 152 / Tuesday, August 9, 2022 / Notices
Application No.
Drug name
Active ingredient(s)
Strength(s)
Dosage form/route
ANDA 083082 ..
CHLOROQUINE PHOSPHATE.
ZORVOLEX .......................
Chloroquine Phosphate .....
250 mg; 500 mg ................
Tablet; Oral ........................
Hikma Pharms.
Diclofenac ..........................
18 mg .................................
Capsule; Oral .....................
Zyla.
NDA 204592 .....
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: August 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17056 Filed 8–8–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2475]
Advisory Committee; Allergenic
Products Advisory Committee,
Renewal
AGENCY:
Food and Drug Administration,
HHS.
Notice; renewal of Federal
advisory committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Allergenic Products
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Allergenic
Products Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until the July 9, 2024,
expiration date.
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SUMMARY:
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Authority for the Allergenic
Products Advisory Committee will
expire on July 9, 2024, unless the
Commissioner formally determines that
renewal is in the public interest.
FOR FURTHER INFORMATION CONTACT:
Sussan Paydar, Division of Scientific
Advisors and Consultants, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10993
New Hampshire Ave., Bldg. 71, Rm.
1333A, Silver Spring, MD 20993–0002,
301–796–4897, Sussan.Paydar@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services and by the General Services
Administration, FDA is announcing the
renewal of the Allergenic Products
Advisory Committee (the Committee).
The Committee is a discretionary
Federal advisory committee established
to provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee shall consist of a core
of nine voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of allergy,
immunology, pediatrics, internal
medicine, biochemistry, and related
specialties. Members will be invited to
serve for overlapping terms of up to 4
years. Almost all non-Federal members
of this committee serve as Special
Government Employees. The core of
voting members may include one
technically qualified member, selected
by the Commissioner or designee, who
is identified with consumer interests
and is recommended by either a
consortium of consumer-oriented
organizations or other interested
persons. In addition to the voting
members, the Committee may include
one non-voting member who is
identified with industry interests.
The Commissioner or designee shall
have the authority to select members of
other scientific and technical FDA
advisory committees (normally not to
exceed 10 members) to serve
temporarily as voting members and to
designate consultants to serve
DATES:
PO 00000
Frm 00036
Fmt 4703
Sfmt 9990
Applicant
temporarily as voting members when:
(1) expertise is required that is not
available among current voting standing
members of the Committee (when
additional voting members are added to
the Committee to provide needed
expertise, a quorum will be based on the
combined total of regular and added
members), or (2) to comprise a quorum
when, because of unforeseen
circumstances, a quorum is or will be
lacking. Because of the size of the
Committee and the variety in the types
of issues that it will consider, FDA may,
in connection with a particular
committee meeting, specify a quorum
that is less than a majority of the current
voting members. The Agency’s
regulations (21 CFR 14.22(d)) authorize
a committee charter to specify quorum
requirements.
If functioning as a medical device
panel, a non-voting representative of
consumer interests and a non-voting
representative of industry interests will
be included in addition to the voting
members.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/advisory-committees/
allergenic-products-advisory-committee/
charter-allergenic-products-advisorycommittee or by contacting the
Designated Federal Officer (see FOR
FURTHER INFORMATION CONTACT). In light
of the fact that no change has been made
to the committee name or description of
duties, no amendment will be made to
21 CFR 14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please visit us at https://www.fda.gov/
AdvisoryCommittees/default.htm.
Dated: August 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17052 Filed 8–8–22; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\09AUN1.SGM
09AUN1
]]>Agencies
[Federal Register Volume 87, Number 152 (Tuesday, August 9, 2022)]
[Notices]
[Pages 48484-48486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17056]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-N-1694]
Determination That AVC (Sulfanilamide) Vaginal Cream, 15%, 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.
[[Page 48485]]
----------------------------------------------------------------------------------------------------------------
Active
Application No. Drug name ingredient(s) Strength(s) Dosage form/route Applicant
----------------------------------------------------------------------------------------------------------------
NDA 006530........ AVC.............. Sulfanilamide.... 15%.............. Cream; Vaginal... Mylan Specialty
LP.
NDA 007936........ SELSUN........... Selenium Sulfide. 2.5%............. Lotion/Shampoo; Chattem, Inc.
Topical.
NDA 008816........ XYLOCAINE........ Lidocaine 2%............... Jelly; Topical... Akorn.
Hydrochloride.
NDA 009218........ COUMADIN......... Warfarin Sodium.. 1 Milligram (mg). Tablet; Oral..... Bristol Myers
Squibb.
NDA 012806........ CORDRAN SP....... Flurandrenolide.. 0.025%........... Cream; Topical... Almirall.
NDA 016647........ QUINAGLUTE....... Quinidine 324 mg........... Tablet, Extended Bayer
Gluconate. Release; Oral. Healthcare.
NDA 017386........ ZAROXOLYN........ Metolazone....... 2.5 mg; 5 mg; 10 Tablet; Oral..... Lannett Co.,
mg. Inc.
NDA 017531........ TIGAN............ Trimethobenzamide 300 mg........... Capsule; Oral.... King Pharms LLC.
Hydrochloride.
NDA 018081........ DEPAKENE......... Valproic Acid.... 250 mg........... Capsule; Oral.... AbbVie Inc.
NDA 018281........ TEGRETOL......... Carbamazepine.... 100 mg........... Tablet, Chewable; Novartis.
Oral.
NDA 018303........ LOPRESSOR HCT.... Hydrochlorothiazi 25mg; 100mg...... Tablet; Oral..... Validus Pharms.
de; Metoprolol
Tartrate.
NDA 018878........ INDOCIN.......... Indomethacin EQ 1 mg Base/Vial Injectable; Recordati Rare
Sodium. Injection. Diseases.
NDA 019404........ OCUFEN........... Flurbiprofen 0.03%............ Solution/Drops; Allergan.
Sodium. Ophthalmic.
NDA 019661........ CYTOVENE......... Ganciclovir EQ 500 mg Base/ Injectable; Cheplapharm.
Sodium. Vial. Injection.
NDA 019697........ ORTHO TRI-CYCLEN. Ethinyl 0.035 mg, 0.035 Tablet; Oral..... Janssen Pharms.
Estradiol; mg, 0.035 mg;
Norgestimate. 0.18 mg, 0.215
mg, 0.25 mg.
NDA 019766........ ZOCOR............ Simvastatin...... 80 mg............ Tablet; Oral..... Organon.
NDA 019814........ BETAGAN.......... Levobunolol 0.25%............ Solution/Drops; Allergan.
Hydrochloride. Ophthalmic.
NDA 019856........ SINEMET CR....... Carbidopa; 25 mg, 100 mg; 50 Tablet, Extended Organon.
Levodopa. mg, 200 mg. Release; Oral.
NDA 019907........ OPTIPRANOLOL..... Metipranolol 0.3%............. Solution/Drops; Bausch and Lomb.
Hydrochloride. Ophthalmic.
NDA 019968........ ULTRAVATE........ Halobetasol 0.05%............ Ointment; Topical Sun Pharm Inds.
Propionate. Inc.
NDA 020010........ LOTRISONE........ Betamethasone EQ 0.05% Base; 1% Lotion; Topical.. Merck Sharp
Dipropionate; Dohme.
Clotrimazole.
NDA 020381........ NIASPAN.......... Niacin........... 500 mg; 750 mg; Tablet, Extended AbbVie Inc.
1g. Release; Oral.
NDA 020412........ ZERIT............ Stavudine........ 15 mg; 20 mg; 30 Capsule; Oral.... Bristol Myers
mg; 40 mg. Squibb.
NDA 020509........ GEMZAR........... Gemcitabine EQ 200 mg Base/ Injectable; Lilly.
Hydrochloride. Vial; 1 Gram (g) Injection.
Base/Vial.
NDA 020593........ DEPACON.......... Valproate Sodium. 100 mg Base/ Injectable; AbbVie Inc.
Milliliter (mL). Injection.
NDA 020615........ DURACLON......... Clonidine 5 mg/10 mL (0.5 Injectable; Mylan
Hydrochloride. mg/mL). Injection. Institutional.
NDA 020718........ INTEGRILIN....... Eptifibatide..... 2 mg/mL; 75 mg/ Injectable; Merck Sharp
100 mL. Injection. Dohme.
NDA 021005........ SOLARAZE......... Diclofenac Sodium 3%............... Gel; Topical..... Fougera Pharms.
NDA 021085........ AVELOX........... Moxifloxacin EQ 400 mg Base... Tablet; Oral..... Bayer
Hydrochloride. Healthcare.
NDA 021183........ VIDEX EC......... Didanosine....... 125 mg; 200 mg; Capsule, Delayed Bristol Myers
250 mg; 400 mg. Release Pellets; Squibb.
Oral.
NDA 021241........ ORTHO TRI-CYCLEN Ethinyl 0.025 mg, 0.025 Tablet; Oral-28.. Janssen Pharms.
LO. Estradiol; mg, 0.025 mg;
Norgestimate. 0.18 mg, 0.215
mg, 0.25 mg.
NDA 021300........ CLARINEX......... Desloratadine.... 0.5 mg/mL........ Solution; Oral... Merck Sharp
Dohme.
NDA 021312........ CLARINEX......... Desloratadine.... 2.5 mg; 5 mg..... Tablet, Orally Organon.
Disintegrating;
Oral.
NDA 021372........ ALOXI............ Palonosetron EQ 0.25 mg Base/5 Injectable; Helsinn
Hydrochloride. mL (EQ 0.05 mg Intravenous. Healthcare.
Base/mL); EQ
0.075 mg Base/
1.5 mL (EQ 0.05
mg Base/mL).
NDA 021444........ RISPERDAL........ Risperidone...... 0.5 mg; 1 mg; 2 Tablet, Orally Janssen Pharms.
mg; 3 mg; 4 mg. Disintegrating;
Oral.
NDA 021455........ BONIVA........... Ibandronate EQ 150 mg Base... Tablet; Oral..... Hoffmann La
Sodium. Roche.
NDA 021605........ CLARINEX D 24 Desloratadine; 5 mg; 240 mg..... Tablet, Extended Organon.
HOUR. Pseudoephedrine Release; Oral.
Sulfate.
NDA 021858........ BONIVA........... Ibandronate EQ 3 mg Base/3 mL Injectable; Hoffmann La
Sodium. Intravenous. Roche.
NDA 021860........ SARAFEM.......... Fluoxetine EQ 10 mg Base; EQ Tablet; Oral..... Allergan.
Hydrochloride. 20 mg Base.
NDA 021956........ DUTOPROL......... Hydrochlorothiazi 12.5 mg; EQ 25 mg Tablet, Extended Concordia.
de; Metoprolol Tartrate; 12.5 Release; Oral.
Succinate. mg: EQ 50 mg
Tartrate; 12.5
mg; EQ 100 mg
Tartrate.
NDA 022064........ XYZAL............ Levocetirizine 5 mg............. Tablet; Oral..... Chattem Sanofi.
Dihydrochloride.
NDA 022106........ DORIBAX.......... Doripenem........ 250 mg/Vial; 500 Injectable; Shionogi, Inc.
mg/Vial. Intravenous
Infusion.
NDA 022129........ ULESFIA.......... Benzyl Alcohol... 5%............... Lotion; Topical.. Shionogi, Inc.
NDA 022157........ XYZAL............ Levocetirizine 2.5 mg/5 mL...... Solution; Oral... Chattem Sanofi.
Dihydrochloride.
NDA 022321........ EMBEDA........... Morphine Sulfate; 20 mg, 0.8 mg; 30 Capsule, Extended Alpharma Pharms.
Naltrexone mg, 1.2 mg; 50 Release; Oral.
Hydrochloride. mg, 2 mg; 60 mg,
2.4 mg; 80 mg,
3.2 mg; 100 mg,
4 mg.
NDA 050261........ DECLOMYCIN....... Demeclocycline 75 mg; 150 mg; Tablet; Oral..... Corepharma.
Hydrochloride. 300 mg.
NDA 050405........ KEFLEX........... Cephalexin....... EQ 250 mg Base; Capsule; Oral.... Pragma.
EQ 500 mg Base;
EQ 750 mg Base.
NDA 050529........ PEDIAZOLE........ Erythromycin EQ 200 mg Base/5 Granule; Oral.... Ross Labs.
Ethylsuccinate; mL; EQ 600 mg
Sulfisoxazole Base/5 mL.
Acetyl.
[[Page 48486]]
ANDA 083082....... CHLOROQUINE Chloroquine 250 mg; 500 mg... Tablet; Oral..... Hikma Pharms.
PHOSPHATE. Phosphate.
NDA 204592........ ZORVOLEX......... Diclofenac....... 18 mg............ Capsule; Oral.... Zyla.
----------------------------------------------------------------------------------------------------------------
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: August 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17056 Filed 8-8-22; 8:45 am]
BILLING CODE 4164-01-P
