SpecGX LLC, et al.; Withdrawal of Approval of 30 Abbreviated New Drug Applications, 22155-22156 [2024-06730]
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Federal Register / Vol. 89, No. 62 / Friday, March 29, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–0020]
SpecGX LLC, et al.; Withdrawal of
Approval of 30 Abbreviated New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
SUMMARY:
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
described 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:
Application No.
Drug
Applicant
ANDA 040163 ......
Meperidine Hydrochloride (HCl) Preservative Free Injectable, 10 milligrams (mg)/milliliters (mL).
Meperidine HCl Tablets, 50 mg and 100 mg ...........................................
Oxycodone and Acetaminophen Solution, 325 mg/5 mL; 5 mg/5 mL .....
Benzphetamine HCl Tablets, 50 mg ........................................................
Ancef in Plastic Container (cefazolin sodium) Injectable, Equivalent to
(EQ) 10 mg base/mL and EQ 20 mg base/mL.
Tizanidine HCl Tablets, EQ 2 mg base and EQ 4 mg base ...................
SpecGx LLC, 385 Marshall Ave., Webster
Groves, MO 63119.
Do.
Do.
Do.
Baxter Healthcare Corp., 1 Baxter Pkwy., Deerfield, IL 60015.
Target Health LLC, U.S. Agent for CASI Pharmaceuticals, Inc., 450 Commerce Boulevard,
Carlstadt, NJ 07072.
Do.
Do.
Do.
ANDA
ANDA
ANDA
ANDA
040352
040680
040773
063002
......
......
......
......
ANDA 076280 ......
ANDA 077021 ......
ANDA 077310 ......
ANDA 077517 ......
ANDA 078319 ......
ANDA 087748 ......
ANDA 087804 ......
ANDA 087846 ......
ANDA 090623 ......
ANDA 202321 ......
ANDA 202946 ......
khammond on DSKJM1Z7X2PROD with NOTICES
withdrawing approval of 30 abbreviated
new drug applications (ANDAs) 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applications be withdrawn.
DATES: Approval is withdrawn as of
April 29, 2024.
FOR FURTHER INFORMATION CONTACT:
Martha Nguyen, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676,
Silver Spring, MD 20993–0002, 240–
402–6980, Martha.Nguyen@fda.hhs.gov.
22155
Cilostazol Tablets, 100 mg .......................................................................
Cilostazol Tablets, 50 mg .........................................................................
Ondansetron HCl Tablets, EQ 4 mg base, EQ 8 mg base, and EQ 24
mg base.
Sumatriptan Succinate Injectable, EQ 4 mg base/0.5 mL (EQ 8 mg
base/mL) and EQ 6 mg base/0.5 mL (EQ 12 mg base/mL).
Blephamide S.O.P (Prednisolone Acetate; Sulfacetamide Sodium) Ointment, 0.2%; 10%.
Butalbital, Acetaminophen, and Caffeine Tablets, 325 mg; 50 mg; 40
mg.
Imipramine HCl Tablets, 10 mg, 25 mg, and 50 mg ...............................
Ranitidine HCl Syrup, EQ 15 mg base/mL ..............................................
ANDA 204823 ......
Oxymorphone HCl Tablets, 5 mg, and 10 mg .........................................
Oxymorphone HCl Extended-Release Tablets, 5 mg, 7.5 mg, 10 mg,
15 mg, 20 mg, 30 mg, and 40 mg.
Cyproheptadine HCl Syrup, 2 mg/5 mL ...................................................
ANDA 206672 ......
ANDA 206710 ......
Entecavir Tablets, 0.5 mg and 1 mg ........................................................
Paricalcitol Capsules, 1 microgram (mcg), 2 mcg, and 4 mcg ................
ANDA
ANDA
ANDA
ANDA
ANDA
......
......
......
......
......
Ranitidine HCl Tablets, EQ 150 mg base ................................................
Ranitidine HCl Tablets, EQ 75 mg base ..................................................
Tenofovir Disoproxil Fumarate Tablets, 300 mg ......................................
Methotrexate Sodium Tablets, EQ 2.5 mg base .....................................
Ranitidine HCl Tablets, EQ 150 mg base ................................................
ANDA 210250 ......
ANDA 211058 ......
ANDA 212312 ......
Ranitidine HCl Tablets, EQ 75 mg base ..................................................
Ranitidine HCl Capsules, EQ 150 mg base and EQ 300 mg base ........
Sildenafil Citrate for Suspension, EQ 10 mg base/mL ............................
ANDA 212626 ......
ANDA 213456 ......
Vigabatrin for Solution, 500 mg/packet ....................................................
Colesevelam HCl Tablets, 625 mg ..........................................................
ANDA 215343 ......
Fluticasone Propionate Ointment, 0.005% ..............................................
207578
207579
209550
209787
210228
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16:49 Mar 28, 2024
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Antares Pharma, Inc., 100 Princeton South Corporate Center, Suite 300, Ewing, NJ 08628.
Allergan Sales, LLC, 2525 Dupont Dr., Irvine, CA
92612.
SpecGx LLC.
Do.
Aurobindo Pharma USA, Inc., U.S. Agent for
Aurobindo Pharma Ltd., 279 PrincetonHightstown Rd., East Windsor, NJ 08520.
SpecGx LLC.
Do.
Patrin Pharma, Inc., P.O. Box 1481, Skokie, IL
60076.
Target Health LLC.
Alvogen PB Research and Development LLC,
U.S. Agent for Lotus Pharmaceutical Co., Ltd.,
Nantou Plant, 44 Whippany Rd, Suite 300,
Morristown, NJ 07960.
Aurobindo Pharma USA, Inc.
Do.
Target Health LLC.
Alvogen PB Research and Development LLC.
PTS Consulting, LLC, U.S. Agent for THINQ
Pharma-CRO Private Ltd., 6739 Vahalla Ct.,
Shawnee, KS 66217.
Do.
Aurobindo Pharma USA, Inc.
Tris Pharma, Inc., 2033 Route 130, Suite D, Monmouth Junction, NJ 08852.
SpecGx LLC.
SPH Phililab Inc., 5207 Militia Hill Rd., Suite 100,
Plymouth Meeting, PA 19462.
BF Suma Pharmaceuticals Inc., U.S. Agent for
Bright Future Pharmaceutical Laboratories Ltd.,
5001 Earle Ave., Rosemead, CA 91770.
E:\FR\FM\29MRN1.SGM
29MRN1
22156
Federal Register / Vol. 89, No. 62 / Friday, March 29, 2024 / Notices
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of April 29,
2024. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
listed in the table without an approved
new drug application or ANDA 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 April 29, 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: March 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–06730 Filed 3–28–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1298]
Over-the-Counter Monograph Drug
User Fee Program—Facility Fee Rates
for Fiscal Year 2024
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the over-the-counter (OTC)
monograph drug facility (MDF) fee rates
under the OTC monograph drug user fee
program (OMUFA) for fiscal year (FY)
2024. The Federal Food, Drug, and
Cosmetic Act (FD&C Act) authorizes
FDA to assess and collect user fees from
qualifying manufacturers of OTC
monograph drugs and submitters of
OTC monograph order requests
(OMORs). This notice publishes the
OMUFA facility fee rates for FY 2024.
DATES: These facility fees are effective
on October 1, 2023, and will remain in
effect through September 30, 2024.
FOR FURTHER INFORMATION CONTACT:
Olufunmilayo (Funmi) Ariyo, Office of
Financial Management, Food and Drug
Administration, 4041 Powder Mill Rd.,
6th Floor, Beltsville, MD 20705–4304,
240–402–4989; or the User Fees Support
Staff at OO-OFBAP-OFM-UFSSGovernment@fda.hhs.gov.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:49 Mar 28, 2024
Jkt 262001
SUPPLEMENTARY INFORMATION:
I. Background
Section 744M of the FD&C Act (21
U.S.C. 379j–72), authorizes FDA to
assess and collect: (1) facility fees from
qualifying owners of OTC monograph
drug facilities and (2) fees from
submitters of qualifying OTC OMORs.
The OTC OMOR fee rates for FY 2024
were published on September 12, 2023.1
These fees are to support FDA’s OTC
monograph drug activities, which are
detailed in section 744L(6) of the FD&C
Act (21 U.S.C. 379j–71(6)) and include
various FDA activities associated with
OTC monograph drugs. For OMUFA
purposes:
• An OTC monograph drug is a
nonprescription drug without an
approved new drug application that is
governed by the provisions of section
505G of the FD&C Act (21 U.S.C. 355h)
(see section 744L(5) of the FD&C Act);
• An OTC MDF is a foreign or
domestic business or other entity that,
in addition to meeting other criteria, is
engaged in manufacturing or processing
the finished dosage form of an OTC
monograph drug (see section 744L(10)
of the FD&C Act); and
• A contract manufacturing
organization (CMO) facility is an OTC
monograph drug facility where neither
the owner nor any affiliate of the owner
or facility sells the OTC monograph
drug produced at such facility directly
to wholesalers, retailers, or consumers
in the United States (see section 744L(2)
of the FD&C Act).
Under section 744M(a)(1)(A) of the
FD&C Act, a facility fee for FY 2024
shall be assessed with respect to each
facility that is identified as an OTC
monograph drug facility during the feeliable period from January 1, 2023,
through December 31, 2023.2 Consistent
with the statute, FDA will assess and
collect facility fees with respect to the
two types of OTC monograph drug
facilities—MDF and CMO facilities. A
full facility fee will be assessed to each
qualifying person that owns a facility
identified as an MDF (see section
744M(a)(1)(A) of the FD&C Act), and a
reduced facility fee of two-thirds will be
assessed to each qualifying person that
owns a facility identified as a CMO
1 https://www.federalregister.gov/documents/
2023/09/12/2023-19609/over-the-countermonograph-drug-user-fee-program-otc-monographorder-requests-fee-rates-for-fiscal.
2 Under section 744M(a)(1) of the FD&C Act,
‘‘Each person that owns a facility identified as an
OTC monograph drug facility on December 31 of
the fiscal year or at any time during the preceding
12-month period shall be assessed an annual fee for
each such facility.’’ For purposes of FY 2024 facility
fees, that time period is January 1, 2023, through
December 31, 2023.
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
facility (see section 744M(a)(1)(B)(ii) of
the FD&C Act). The facility fees for FY
2024 are due on June 3, 2024 (see
section 744M(a)(1)(D)(ii) of the FD&C
Act).3
As discussed in greater detail below:
• OTC monograph drug facilities are
exempt from FY 2024 facility fees if
they had ceased OTC monograph drug
activities, and updated their registration
with FDA to that effect, prior to
December 31, 2022 (see section
744M(a)(1)(B)(i) of the FD&C Act).
• Entities that registered with FDA
during the Coronavirus Disease 2019
(COVID–19) pandemic whose sole
activity with respect to OTC monograph
drugs during the pandemic consists (or
had consisted) of manufacturing OTC
hand sanitizer products 4 are not
identified as OTC monograph drug
facilities subject to OMUFA facility fees
for FY 2024.5
For FY 2024, the OMUFA facility fee
rates are: MDF facility fees ($34,166)
and CMO facility fees ($22,777). These
fees are effective for the period from
October 1, 2023, through September 30,
2024.6 This document is issued
pursuant to section 744M(a)(4) and
744M(c)(4)(B) of the FD&C Act and
describes the calculations used to set
the OMUFA facility fees for FY 2024 in
accordance with the directives in the
statute.
II. Facility Fee Revenue Amount for FY
2024
A. Base Fee Revenue Amount
Under OMUFA, FDA sets annual
facility fees to generate the total facility
fee revenues for each fiscal year
3 Assuming that, as we anticipate, the FY 2024 fee
appropriation will occur prior to June 3, 2024.
Under section 744M(a)(1)(D)(ii), the FY 2024
facility fees are due on the later of: (1) the first
business day of June 2024 (i.e., June 3, 2024) or (2)
the first business day after the enactment of an
appropriations Act providing for the collection and
obligation of FY 2024 OMUFA fees.
4 The term ‘‘hand sanitizer’’ commonly refers to
consumer antiseptic rubs. However, because the
Department of Health and Human Services (HHS)
notice published January 12, 2021, referred to
‘‘persons that entered the over-the-counter drug
market to supply hand sanitizer products in
response to the COVID–19 Public Health
Emergency’’ (86 FR 2420 https://www.federal
register.gov/documents/2021/01/12/2021-00237/
notice-that-persons-that-entered-the-over-thecounter-drug-market-to-supply-hand-sanitizerduring), we are using the same terminology—‘‘hand
sanitizer products’’—to refer to OTC monograph
drug products intended for use (without water) as
antiseptic hand rubs or antiseptic hand wipes by
consumers or healthcare personnel.
5 See HHS Federal Register notice of January 12,
2021, 86 FR 2420, https://www.federalregister.gov/
documents/2021/01/12/2021-00237/notice-thatpersons-that-entered-the-over-the-counter-drugmarket-to-supply-hand-sanitizer-during.
6 These OMUFA fees are for FY 2024, per section
744M(a) of the FD&C Act.
E:\FR\FM\29MRN1.SGM
29MRN1
]]>Agencies
[Federal Register Volume 89, Number 62 (Friday, March 29, 2024)]
[Notices]
[Pages 22155-22156]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-06730]
[[Page 22155]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-0020]
SpecGX LLC, et al.; Withdrawal of Approval of 30 Abbreviated New
Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
withdrawing approval of 30 abbreviated new drug applications (ANDAs)
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 April 29, 2024.
FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, [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 described 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.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 040163............... Meperidine Hydrochloride SpecGx LLC, 385
(HCl) Preservative Free Marshall Ave.,
Injectable, 10 Webster Groves,
milligrams (mg)/ MO 63119.
milliliters (mL).
ANDA 040352............... Meperidine HCl Tablets, Do.
50 mg and 100 mg.
ANDA 040680............... Oxycodone and Do.
Acetaminophen Solution,
325 mg/5 mL; 5 mg/5 mL.
ANDA 040773............... Benzphetamine HCl Do.
Tablets, 50 mg.
ANDA 063002............... Ancef in Plastic Baxter Healthcare
Container (cefazolin Corp., 1 Baxter
sodium) Injectable, Pkwy., Deerfield,
Equivalent to (EQ) 10 IL 60015.
mg base/mL and EQ 20 mg
base/mL.
ANDA 076280............... Tizanidine HCl Tablets, Target Health LLC,
EQ 2 mg base and EQ 4 U.S. Agent for
mg base. CASI
Pharmaceuticals,
Inc., 450
Commerce
Boulevard,
Carlstadt, NJ
07072.
ANDA 077021............... Cilostazol Tablets, 100 Do.
mg.
ANDA 077310............... Cilostazol Tablets, 50 Do.
mg.
ANDA 077517............... Ondansetron HCl Tablets, Do.
EQ 4 mg base, EQ 8 mg
base, and EQ 24 mg base.
ANDA 078319............... Sumatriptan Succinate Antares Pharma,
Injectable, EQ 4 mg Inc., 100
base/0.5 mL (EQ 8 mg Princeton South
base/mL) and EQ 6 mg Corporate Center,
base/0.5 mL (EQ 12 mg Suite 300, Ewing,
base/mL). NJ 08628.
ANDA 087748............... Blephamide S.O.P Allergan Sales,
(Prednisolone Acetate; LLC, 2525 Dupont
Sulfacetamide Sodium) Dr., Irvine, CA
Ointment, 0.2%; 10%. 92612.
ANDA 087804............... Butalbital, SpecGx LLC.
Acetaminophen, and
Caffeine Tablets, 325
mg; 50 mg; 40 mg.
ANDA 087846............... Imipramine HCl Tablets, Do.
10 mg, 25 mg, and 50 mg.
ANDA 090623............... Ranitidine HCl Syrup, EQ Aurobindo Pharma
15 mg base/mL. USA, Inc., U.S.
Agent for
Aurobindo Pharma
Ltd., 279
Princeton-
Hightstown Rd.,
East Windsor, NJ
08520.
ANDA 202321............... Oxymorphone HCl Tablets, SpecGx LLC.
5 mg, and 10 mg.
ANDA 202946............... Oxymorphone HCl Extended- Do.
Release Tablets, 5 mg,
7.5 mg, 10 mg, 15 mg,
20 mg, 30 mg, and 40 mg.
ANDA 204823............... Cyproheptadine HCl Patrin Pharma,
Syrup, 2 mg/5 mL. Inc., P.O. Box
1481, Skokie, IL
60076.
ANDA 206672............... Entecavir Tablets, 0.5 Target Health LLC.
mg and 1 mg.
ANDA 206710............... Paricalcitol Capsules, 1 Alvogen PB
microgram (mcg), 2 mcg, Research and
and 4 mcg. Development LLC,
U.S. Agent for
Lotus
Pharmaceutical
Co., Ltd., Nantou
Plant, 44
Whippany Rd,
Suite 300,
Morristown, NJ
07960.
ANDA 207578............... Ranitidine HCl Tablets, Aurobindo Pharma
EQ 150 mg base. USA, Inc.
ANDA 207579............... Ranitidine HCl Tablets, Do.
EQ 75 mg base.
ANDA 209550............... Tenofovir Disoproxil Target Health LLC.
Fumarate Tablets, 300
mg.
ANDA 209787............... Methotrexate Sodium Alvogen PB
Tablets, EQ 2.5 mg base. Research and
Development LLC.
ANDA 210228............... Ranitidine HCl Tablets, PTS Consulting,
EQ 150 mg base. LLC, U.S. Agent
for THINQ Pharma-
CRO Private Ltd.,
6739 Vahalla Ct.,
Shawnee, KS
66217.
ANDA 210250............... Ranitidine HCl Tablets, Do.
EQ 75 mg base.
ANDA 211058............... Ranitidine HCl Capsules, Aurobindo Pharma
EQ 150 mg base and EQ USA, Inc.
300 mg base.
ANDA 212312............... Sildenafil Citrate for Tris Pharma, Inc.,
Suspension, EQ 10 mg 2033 Route 130,
base/mL. Suite D, Monmouth
Junction, NJ
08852.
ANDA 212626............... Vigabatrin for Solution, SpecGx LLC.
500 mg/packet.
ANDA 213456............... Colesevelam HCl Tablets, SPH Phililab Inc.,
625 mg. 5207 Militia Hill
Rd., Suite 100,
Plymouth Meeting,
PA 19462.
ANDA 215343............... Fluticasone Propionate BF Suma
Ointment, 0.005%. Pharmaceuticals
Inc., U.S. Agent
for Bright Future
Pharmaceutical
Laboratories
Ltd., 5001 Earle
Ave., Rosemead,
CA 91770.
------------------------------------------------------------------------
[[Page 22156]]
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of April
29, 2024. Approval of each entire application is withdrawn, including
any strengths and dosage forms inadvertently missing from the table.
Introduction or delivery for introduction into interstate commerce of
products listed in the table without an approved new drug application
or ANDA 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 April 29, 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: March 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-06730 Filed 3-28-24; 8:45 am]
BILLING CODE 4164-01-P
