PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.; Withdrawal of Approval of 23 New Drug Applications, 30379-30380 [2024-08657]
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30379
Federal Register / Vol. 89, No. 79 / Tuesday, April 23, 2024 / Notices
10. Title: Medicaid Extended
Postpartum Coverage and Continuous
Eligibility for Children
Type of Request: Extension of a
currently approved collection.
CMS ID Number: CMS–10434 #77.
OMB Control Number: 0938–1188.
eRulemaking Docket ID Number:
CMS–2023–0088.
Docket Web Address: https://
www.regulations.gov/docket/CMS-20230088.
For Policy Related Questions, Contact:
Alexa Turner at 410–786–8823.
William N. Parham, III,
Director, Division of Information Collections
and Regulatory Impacts, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2024–08658 Filed 4–22–24; 8:45 am]
Administration for Children and
Families
Proposed Information Collection
Activity; Community Services Block
Grant (CSBG) Model Tribal Plan and
Application (New Collection)
Office of Community Services,
Administration for Children and
Families, U.S. Department of Health and
Human Services.
AGENCY:
ACTION:
Request for public comments.
The Office of Community
Services (OCS), Administration for
Children and Families (ACF), requests
an approval of the Community Services
Block Grant (CSBG) Model Tribal Plan.
SUMMARY:
Comments due within 60 days of
publication. In compliance with the
requirements of the Paperwork
Reduction Act of 1995, ACF is soliciting
public comment on the specific aspects
of the information collection described
above.
DATES:
BILLING CODE 4120–01–P
You can obtain copies of the
proposed collection of information and
submit comments by emailing
infocollection@acf.hhs.gov. Identify all
requests by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
Description: Section 677 of the CSBG
Act requires Indian tribes or tribal
organizations to submit an application
and plan (CSBG Model Tribal Plan). The
CSBG Model Tribal Plan must meet
statutory requirements prior to OCS
awarding CSBG tribal grant recipients
with CSBG funds. Tribal grant
recipients have the option to submit a
detailed plan annually or biannually.
Tribal grant recipients that submit a
biannual plan must provide an
abbreviated plan the following year if
substantial changes to the initial plan
will occur. The CSBG Model Tribal Plan
has been used in previous years without
OMB approval. To come into
compliance with the PRA, ACF is
submitting the CSBG Model Tribal Plan
as a new request to OMB.
Respondents: Tribal grant recipients
(tribes and tribal organizations)
ADDRESSES:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ANNUAL BURDEN ESTIMATES
Instrument
Total number
of respondents
Annual number
of responses
per respondent
Average
burden hours
per response
Annual
burden
hours
CSBG Model Tribal Plan .........................................................................
66
1
10
660
ddrumheller on DSK120RN23PROD with NOTICES1
Comments: The Department
specifically requests comments on (a)
whether the proposed collection of
information is necessary for the proper
performance of the functions of the
agency, including whether the
information shall have practical utility;
(b) the accuracy of the agency’s estimate
of the burden of the proposed collection
of information; (c) the quality, utility,
and clarity of the information to be
collected; and (d) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection techniques
or other forms of information
technology. Consideration will be given
to comments and suggestions submitted
within 60 days of this publication.
Authority: Sec. 677, Pub. L. 105–285,
112 Stat. 2742 (42 U.S.C. 9911)
Mary C. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2024–08668 Filed 4–22–24; 8:45 am]
BILLING CODE 4184–27–P
VerDate Sep<11>2014
17:48 Apr 22, 2024
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1786]
PAI Holdings, LLC DBA
Pharmaceutical Associates, Inc., et al.;
Withdrawal of Approval of 23 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 23 new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
May 23, 2024.
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\23APN1.SGM
23APN1
30380
Federal Register / Vol. 89, No. 79 / Tuesday, April 23, 2024 / Notices
Application No.
Drug
NDA 007959 ......
Tensilon (edrophonium chloride) Injection, 10 milligrams
(mg)/milliliter (mL).
Tensilon Preservative Free (edrophonium chloride) Injection,
10 mg/mL.
Cortef (hydrocortisone cypionate) Oral Suspension, Equivalent to (EQ) 10 mg base/5 mL.
Haldol (haloperidol lactate) Injection, EQ 5 mg base/mL ........
NDA 009900 ......
NDA 015923 ......
NDA 017090 ......
NDA 018309 ......
Tofranil-PM (imipramine pamoate) Capsules, EQ 75 mg hydrochloride (HCl), EQ 100 mg HCl, EQ 125 mg HCl, and
EQ 150 mg HCl.
Topicort LP (desoximetasone) Emollient Cream, 0.05% .........
NDA 018401 ......
Buprenex (buprenorphine HCl) Injection, EQ 0.3 mg base/mL
NDA 019201 ......
Voltaren (diclofenac sodium) Delayed-Release Tablets, 25
mg, 50 mg, and 75 mg.
Trandate (labetalol HCl) Injection, 5 mg/mL ............................
NDA 019425 ......
NDA 020142 ......
NDA 020254 ......
NDA 020631 ......
NDA 020768 ......
NDA 020897 ......
NDA 020945 ......
NDA 021226 ......
NDA 021231 ......
NDA 021360 ......
NDA 022484 ......
NDA 050679 ......
NDA 203696 ......
NDA 206302 ......
NDA 208042 ......
NDA 208437 ......
ddrumheller on DSK120RN23PROD with NOTICES1
Applicant
Cataflam (diclofenac potassium) Tablets, 25 mg and 50 mg ..
Voltaren XR (diclofenac sodium) Extended-Release Tablets,
100 mg.
Morphine Sulfate Injection, 1 mg/mL and 2 mg/mL ................
Zomig (zolmitriptan) Tablets, 2.5 mg and 5 mg ......................
Ditropan XL (oxybutynin chloride) Extended-Release Tablets,
5 mg, 10 mg, and 15 mg.
Norvir (ritonavir) Capsules, 100 mg .........................................
Kaletra (lopinavir/ritonavir) Capsules, 133.3 mg/33.3 mg .......
Zomig-ZMT (zolmitriptan) Orally Disintegrating Tablets, 2.5
mg and 5 mg.
Sustiva (efavirenz) Tablets, 300 mg and 600 mg ...................
Onmel (itraconazole) Tablets, 200 mg ....................................
Maxipime (cefepime HCl) for Injection, EQ 500 mg base/vial,
EQ 1 gram base/vial, and EQ 2 gram base/vial.
Lupaneta Pack (leuprolide acetate injection and
norethindrone acetate Tablets), 3.75 mg/vial;5 mg and
11.25 mg/vial;5 mg.
Byvalson (nebivolol HCl/valsartan) Tablets, EQ 5 mg base/80
mg.
Cassipa (buprenorphine HCl/naloxone HCl) Sublingual Film,
EQ 16 mg base/EQ 4 mg base.
Lonhala Magnair Kit (glycopyrrolate) Inhalation Solution, 25
microgram/mL.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of May 23, 2024.
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 listed in the table
without an approved NDA violates
sections 505(a) and 301(d) of the Federal
Food, Drug, and Cosmetic Act (21 U.S.C.
355(a) and 331(d)). Drug products that
are listed in the table that are in
inventory on May 23, 2024, 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.
VerDate Sep<11>2014
17:48 Apr 22, 2024
Jkt 262001
PAI Holdings, LLC dba Pharmaceutical Associates, Inc.,
1700 Perimeter Rd., Greenville, SC 29605.
Pharmacia and Upjohn Co., 66 Hudson Blvd. East, New
York, NY 10001.
Janssen Pharmaceuticals, Inc., 1000 U.S. Route 202, Raritan, NJ 08869.
SpecGx LLC, 385 Marshall Ave., Webster Groves, MO
63119.
Taro Pharmaceuticals U.S.A., Inc., 3 Skyline Dr., Hawthorne,
NY 10532.
Indivior Inc., 10710 Midlothian Turnpike, Suite 125, North
Chesterfield, VA 23235.
Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936.
Sebela Ireland Limited, c/o Sebela Pharmaceuticals Inc., 645
Hembree Pkwy., Suite 1, Roswell, GA 30076.
Novartis Pharmaceuticals Corp.
Do.
SpecGx LLC.
iPR Pharmaceuticals, Inc., c/o AstraZeneca Pharmaceuticals
LP, 1800 Concord Pike, Wilmington, DE 19803.
Janssen Pharmaceuticals, Inc.
AbbVie Inc., 1 N. Waukegan Rd., North Chicago, IL 60064.
Do.
iPR Pharmaceuticals, Inc., c/o AstraZeneca Pharmaceuticals
LP.
Bristol-Myers Squibb Company, P.O. Box 4000, Princeton,
NJ 08543–4000.
Sebela Ireland Limited, c/o Sebela Pharmaceuticals Inc.
Hospira Inc, 275 North Field Dr., Bldg. H1–3S, Lake Forest,
IL 60045.
AbbVie Endocrinology Inc., 1 N Waukegan Rd., North Chicago, IL 60064.
AbbVie Inc.
Teva Pharmaceuticals USA, Inc., 577 Chipeta Way, Salt
Lake City, UT 84108.
Sumitomo Pharma America, Inc., 84 Waterford Dr., Marlborough, MA 01752.
Dated: April 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–08657 Filed 4–22–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0946]
Report on the Performance of Drug
and Biologics Firms in Conducting
Postmarketing Requirements and
Commitments; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
announcing the availability of the
Agency’s annual report entitled ‘‘Report
on the Performance of Drug and
Biologics Firms in Conducting
Postmarketing Requirements and
Commitments.’’ Under the Federal
Food, Drug, and Cosmetic Act (FD&C
Act), FDA is required to report annually
on the status of postmarketing
requirements (PMRs) and postmarketing
commitments (PMCs) required of, or
agreed upon by, application holders of
approved drug and biological products.
The report on the status of the studies
and clinical trials that applicants are
required to, or have agreed to, conduct
is on the FDA’s website entitled
‘‘Postmarketing Requirements and
Commitments: Reports’’ (https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/PostmarketingPhaseIVCommitments/
ucm064436.htm).
E:\FR\FM\23APN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 79 (Tuesday, April 23, 2024)]
[Notices]
[Pages 30379-30380]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-08657]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1786]
PAI Holdings, LLC DBA Pharmaceutical Associates, Inc., et al.;
Withdrawal of Approval of 23 New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 23 new drug applications (NDAs) from multiple
applicants. The applicants notified the Agency in writing that the drug
products were no longer marketed and requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of May 23, 2024.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137, [email protected].
SUPPLEMENTARY INFORMATION: The applicants listed in the table have
informed FDA that these drug products are no longer marketed and have
requested that FDA withdraw approval of the applications under the
process in Sec. 314.150(c) (21 CFR 314.150(c)). The applicants have
also, by their requests, waived their opportunity for a hearing.
Withdrawal of approval of an application or abbreviated application
under Sec. 314.150(c) is without prejudice to refiling.
[[Page 30380]]
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 007959............. Tensilon (edrophonium PAI Holdings, LLC dba
chloride) Injection, Pharmaceutical
10 milligrams (mg)/ Associates, Inc.,
milliliter (mL). 1700 Perimeter Rd.,
Tensilon Preservative Greenville, SC 29605.
Free (edrophonium
chloride) Injection,
10 mg/mL.
NDA 009900............. Cortef (hydrocortisone Pharmacia and Upjohn
cypionate) Oral Co., 66 Hudson Blvd.
Suspension, Equivalent East, New York, NY
to (EQ) 10 mg base/5 10001.
mL.
NDA 015923............. Haldol (haloperidol Janssen
lactate) Injection, EQ Pharmaceuticals,
5 mg base/mL. Inc., 1000 U.S. Route
202, Raritan, NJ
08869.
NDA 017090............. Tofranil-PM (imipramine SpecGx LLC, 385
pamoate) Capsules, EQ Marshall Ave.,
75 mg hydrochloride Webster Groves, MO
(HCl), EQ 100 mg HCl, 63119.
EQ 125 mg HCl, and EQ
150 mg HCl.
NDA 018309............. Topicort LP Taro Pharmaceuticals
(desoximetasone) U.S.A., Inc., 3
Emollient Cream, 0.05%. Skyline Dr.,
Hawthorne, NY 10532.
NDA 018401............. Buprenex (buprenorphine Indivior Inc., 10710
HCl) Injection, EQ 0.3 Midlothian Turnpike,
mg base/mL. Suite 125, North
Chesterfield, VA
23235.
NDA 019201............. Voltaren (diclofenac Novartis
sodium) Delayed- Pharmaceuticals
Release Tablets, 25 Corp., 1 Health
mg, 50 mg, and 75 mg. Plaza, East Hanover,
NJ 07936.
NDA 019425............. Trandate (labetalol Sebela Ireland
HCl) Injection, 5 mg/ Limited, c/o Sebela
mL. Pharmaceuticals Inc.,
645 Hembree Pkwy.,
Suite 1, Roswell, GA
30076.
NDA 020142............. Cataflam (diclofenac Novartis
potassium) Tablets, 25 Pharmaceuticals Corp.
mg and 50 mg.
NDA 020254............. Voltaren XR (diclofenac Do.
sodium) Extended-
Release Tablets, 100
mg.
NDA 020631............. Morphine Sulfate SpecGx LLC.
Injection, 1 mg/mL and
2 mg/mL.
NDA 020768............. Zomig (zolmitriptan) iPR Pharmaceuticals,
Tablets, 2.5 mg and 5 Inc., c/o AstraZeneca
mg. Pharmaceuticals LP,
1800 Concord Pike,
Wilmington, DE 19803.
NDA 020897............. Ditropan XL (oxybutynin Janssen
chloride) Extended- Pharmaceuticals, Inc.
Release Tablets, 5 mg,
10 mg, and 15 mg.
NDA 020945............. Norvir (ritonavir) AbbVie Inc., 1 N.
Capsules, 100 mg. Waukegan Rd., North
Chicago, IL 60064.
NDA 021226............. Kaletra (lopinavir/ Do.
ritonavir) Capsules,
133.3 mg/33.3 mg.
NDA 021231............. Zomig-ZMT iPR Pharmaceuticals,
(zolmitriptan) Orally Inc., c/o AstraZeneca
Disintegrating Pharmaceuticals LP.
Tablets, 2.5 mg and 5
mg.
NDA 021360............. Sustiva (efavirenz) Bristol-Myers Squibb
Tablets, 300 mg and Company, P.O. Box
600 mg. 4000, Princeton, NJ
08543-4000.
NDA 022484............. Onmel (itraconazole) Sebela Ireland
Tablets, 200 mg. Limited, c/o Sebela
Pharmaceuticals Inc.
NDA 050679............. Maxipime (cefepime HCl) Hospira Inc, 275 North
for Injection, EQ 500 Field Dr., Bldg. H1-
mg base/vial, EQ 1 3S, Lake Forest, IL
gram base/vial, and EQ 60045.
2 gram base/vial.
NDA 203696............. Lupaneta Pack AbbVie Endocrinology
(leuprolide acetate Inc., 1 N Waukegan
injection and Rd., North Chicago,
norethindrone acetate IL 60064.
Tablets), 3.75 mg/
vial;5 mg and 11.25 mg/
vial;5 mg.
NDA 206302............. Byvalson (nebivolol HCl/ AbbVie Inc.
valsartan) Tablets, EQ
5 mg base/80 mg.
NDA 208042............. Cassipa (buprenorphine Teva Pharmaceuticals
HCl/naloxone HCl) USA, Inc., 577
Sublingual Film, EQ 16 Chipeta Way, Salt
mg base/EQ 4 mg base. Lake City, UT 84108.
NDA 208437............. Lonhala Magnair Kit Sumitomo Pharma
(glycopyrrolate) America, Inc., 84
Inhalation Solution, Waterford Dr.,
25 microgram/mL. Marlborough, MA
01752.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of May
23, 2024. 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 listed in the table
without an approved NDA violates sections 505(a) and 301(d) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)).
Drug products that are listed in the table that are in inventory on May
23, 2024, 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: April 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-08657 Filed 4-22-24; 8:45 am]
BILLING CODE 4164-01-P
