Discovery Therapeutics, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications, 64506 [2021-25111]
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64506
Federal Register / Vol. 86, No. 220 / Thursday, November 18, 2021 / Notices
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 18 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applications be withdrawn.
SUMMARY:
[FR Doc. 2021–25103 Filed 11–17–21; 8:45 am]
BILLING CODE 4120–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–1195]
Approval is withdrawn as of
December 20, 2021.
DATES:
Discovery Therapeutics, LLC, et al.;
Withdrawal of Approval of 18
Abbreviated New Drug Applications
AGENCY:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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 040619 .........
Methimazole Tablets, 15 milligrams (mg) .............................
ANDA 070254 .........
Naloxone Hydrochloride (HCl) Injection, 0.4 mg/milliliters
(mL).
Bupivacaine HCl Injection, 0.25% .........................................
Morphine Sulfate Injection, 1 mg/mL ....................................
Desmopressin Acetate Injection, 0.004 mg/mL ....................
Tretinoin Cream, 0.05% ........................................................
Ciprofloxacin Injection, 200 mg/20 mL (10 mg/mL) and 400
mg/40 mL (10 mg/mL).
Lidocaine HCl Solution, 4% ...................................................
Chloroprocaine HCl Injection, 3% .........................................
Chloroprocaine HCl Injection, 2% .........................................
Levocetirizine Dihydrochloride Tablets, 5 mg .......................
Discovery Therapeutics, LLC, 2831 Deer Hound Way, Palm
Harbor, FL 34683.
Hospira, Inc., 275 North Field Dr., Building H1, Lake Forest, IL 60045.
Do.
Do.
Do.
ZO Skin Health, Inc., 9685 Research Dr., Irvine, CA 92618.
Hospira, Inc.
ANDA
ANDA
ANDA
ANDA
ANDA
070586
071850
075220
076498
077245
.........
.........
.........
.........
.........
ANDA
ANDA
ANDA
ANDA
080409
087446
087447
201653
.........
.........
.........
.........
ANDA 202524 .........
ANDA 202857 .........
ANDA 203885 .........
ANDA 207864 .........
ANDA 209489 .........
ANDA 210283 .........
ANDA 210855 .........
khammond on DSKJM1Z7X2PROD with NOTICES
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.
Levetiracetam Extended Release Tablets, 500 mg and 750
mg.
Daptomycin Powder for Injection, 500 mg/vial ......................
Amiodarone HCl Injection, 50 mg/mL ...................................
Eptifibatide Injection, 2 mg/mL and 75 mg/100 mL ..............
Caspofungin Acetate Powder for Injection, 50 mg/vial and
70 mg/vial.
Clofarabine Injection, 20 mg/20 mL (1 mg/mL) ....................
Sodium Nitroprusside Injection, 25 mg/mL ...........................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of December 20,
2021. 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
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
that are in inventory on December 20,
2021 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
Do.
Do.
Do.
Sun Pharmaceutical Industries, Inc., U.S. Agent for Sun
Pharmaceutical Industries Ltd., 270 Prospect Plains Rd.,
Cranbury, NJ 08512.
Rouses Point Pharmaceuticals, LLC, 11 Commerce Dr.,
Cranford, NJ 07016.
Hospira, Inc.
Do.
The WhiteOak Group, LLC, U.S. Agent for Hybio Pharmaceutical Co., Ltd., 1629 K St. NW, Suite 300, Washington, DC 20006.
Cipla USA, Inc., U.S. Agent for Cipla Limited, 10 Independence Blvd., Suite 300, Warren, NJ 07059.
Hospira, Inc.
Cipla USA, Inc.
17:11 Nov 17, 2021
Jkt 256001
Dated: November 12, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development; Notice of Closed
Meeting
The meeting will be closed to the
public as indicated below in accordance
with the provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended for the review, discussion,
and evaluation of individual intramural
programs and projects conducted by the
Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, including consideration
of personnel qualifications and
performance, and the competence of
individual investigators, the disclosure
of which would constitute a clearly
unwarranted invasion of personal
privacy.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Board of Scientific
Counselors, NICHD.
Name of Committee: Board of Scientific
Counselors, NICHD.
Date: December 3, 2021.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: A report by the Acting Scientific
Director, NICHD, on the status of the NICHD
[FR Doc. 2021–25111 Filed 11–17–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
PO 00000
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[Federal Register Volume 86, Number 220 (Thursday, November 18, 2021)]
[Notices]
[Page 64506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25111]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-1195]
Discovery Therapeutics, LLC, et al.; Withdrawal of Approval of 18
Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 18 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 December 20, 2021.
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].hhs.gov.
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 040619............... Methimazole Tablets, Discovery
15 milligrams (mg). Therapeutics, LLC,
2831 Deer Hound Way,
Palm Harbor, FL
34683.
ANDA 070254............... Naloxone Hospira, Inc., 275
Hydrochloride (HCl) North Field Dr.,
Injection, 0.4 mg/ Building H1, Lake
milliliters (mL). Forest, IL 60045.
ANDA 070586............... Bupivacaine HCl Do.
Injection, 0.25%.
ANDA 071850............... Morphine Sulfate Do.
Injection, 1 mg/mL.
ANDA 075220............... Desmopressin Acetate Do.
Injection, 0.004 mg/
mL.
ANDA 076498............... Tretinoin Cream, ZO Skin Health, Inc.,
0.05%. 9685 Research Dr.,
Irvine, CA 92618.
ANDA 077245............... Ciprofloxacin Hospira, Inc.
Injection, 200 mg/20
mL (10 mg/mL) and
400 mg/40 mL (10 mg/
mL).
ANDA 080409............... Lidocaine HCl Do.
Solution, 4%.
ANDA 087446............... Chloroprocaine HCl Do.
Injection, 3%.
ANDA 087447............... Chloroprocaine HCl Do.
Injection, 2%.
ANDA 201653............... Levocetirizine Sun Pharmaceutical
Dihydrochloride Industries, Inc.,
Tablets, 5 mg. U.S. Agent for Sun
Pharmaceutical
Industries Ltd., 270
Prospect Plains Rd.,
Cranbury, NJ 08512.
ANDA 202524............... Levetiracetam Rouses Point
Extended Release Pharmaceuticals,
Tablets, 500 mg and LLC, 11 Commerce
750 mg. Dr., Cranford, NJ
07016.
ANDA 202857............... Daptomycin Powder for Hospira, Inc.
Injection, 500 mg/
vial.
ANDA 203885............... Amiodarone HCl Do.
Injection, 50 mg/mL.
ANDA 207864............... Eptifibatide The WhiteOak Group,
Injection, 2 mg/mL LLC, U.S. Agent for
and 75 mg/100 mL. Hybio Pharmaceutical
Co., Ltd., 1629 K
St. NW, Suite 300,
Washington, DC
20006.
ANDA 209489............... Caspofungin Acetate Cipla USA, Inc., U.S.
Powder for Agent for Cipla
Injection, 50 mg/ Limited, 10
vial and 70 mg/vial. Independence Blvd.,
Suite 300, Warren,
NJ 07059.
ANDA 210283............... Clofarabine Hospira, Inc.
Injection, 20 mg/20
mL (1 mg/mL).
ANDA 210855............... Sodium Nitroprusside Cipla USA, Inc.
Injection, 25 mg/mL.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
December 20, 2021. 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 without approved new drug applications violates
section 301(a) and (d) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in the table that
are in inventory on December 20, 2021 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: November 12, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25111 Filed 11-17-21; 8:45 am]
BILLING CODE 4164-01-P
