Hospira, Inc., et al.; Withdrawal of Approval of 27 New Drug Applications, 83973-83975 [2020-28346]
Download as PDF
<![CDATA[
Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices
meaningfully reduce abuse and declined
the company’s request to include
labeling describing potentially abusedeterrent properties for OPANA ER.
Based on postmarketing data, FDA
later observed that there was a
significant shift in the route of abuse
from nasal to injection following the
product’s reformulation. Injection abuse
of reformulated OPANA ER has been
associated with a serious outbreak of
HIV and hepatitis C, as well as cases of
a serious blood disorder (thrombotic
microangiopathy). On June 8, 2017, FDA
requested that Endo remove
reformulated OPANA ER from the
market based on its concern that the
benefits of the drug may no longer
outweigh its risks due to the public
health consequences of abuse (see
https://www.fda.gov/news-events/pressannouncements/fda-requests-removalopana-er-risks-related-abuse). On July 6,
2017, Endo announced it would
voluntarily remove reformulated
OPANA ER from the market.
On October 3, 2017, Endo requested
withdrawal of NDA 201655 for
reformulated OPANA ER under
§ 314.150(d) (21 CFR 314.150(d)) and
waived its opportunity for a hearing. For
the reasons discussed above, and
pursuant to the applicant’s request,
Dated: December 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–28283 Filed 12–22–20; 8:45 am]
BILLING CODE 4164–01–P
SUMMARY: The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 27 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applications be withdrawn.
Approval is withdrawn as of
January 22, 2021.
DATES:
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.
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:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2272]
Hospira, Inc., et al.; Withdrawal of
Approval of 27 New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Application No.
Drug
NDA 008809 .............
M.V.I.-12 Adult (ascorbic acid, biotin, cyanocobalamin, dexpanthenol,
ergocalciferol, folic acid, niacinamide, pyridoxine hydrochloride (HCl), riboflavin 5’-phosphate sodium, thiamine HCl, vitamin A, and vitamin E) Injection, 10 milligrams (mg)/milliliters (mL), 0.006 mg/mL, 0.5 micrograms (mcg)/
mL, 1.5 mg/mL, 20 International Units (IU)/mL, 0.04 mg/mL, 4 mg/mL, 0.4
mg/mL, 0.36 mg/mL, 0.3 mg/mL, 330 Units/mL, and 1 IU/mL; and 20 mg/mL,
0.006 mg/mL, 0.05 mcg/mL, 1.5 mg/mL, 0.0005 mg/mL, 0.06 mg/mL, 4 mg/
mL, 0.6 mg/mL, 0.36 mg/mL, 0.6 mg/mL, 0.1 mg/mL, and 1 mg/mL.
M.V.I.-12 Adult (ascorbic acid, biotin, cyanocobalamin, dexpanthenol,
ergocalciferol, folic acid, niacinamide, pyridoxine HCl, riboflavin, thiamine
HCl, vitamin A, and vitamin E) Injection, 20 mg/mL, 0.006 mg/mL, 0.5 mcg/
mL, 1.5 mg/mL, 20 IU/mL, 0.6 mg/mL, 4 mg/mL, 0.4 mg/mL, 0.36 mg/mL,
0.6 mg/mL, 330 Units/mL, and 1 IU/mL..
Aminosyn (amino acids) Injection, 5% (5 grams (g)/100 mL), 7% (7 g/100 mL),
7% (pH6) (7 g/100 mL), 8.5% (8.5 g/100 mL), 8.5% (pH6) (8.5 g/100 mL),
10% (10 g/100 mL), and 10% (pH6) (10 g/100 mL).
Aminosyn 8.5% With Electrolytes (amino acids, magnesium chloride, potassium chloride, sodium chloride, and sodium phosphate dibasic) Injection,
8.5% (8.5 g/100mL), 102 mg/100 mL, 487 mg/100 mL, 28 mg/100 mL, and
425 mg/100 mL..
Aminosyn 8.5% With Electrolytes (amino acids, magnesium chloride, potassium phosphate dibasic, and sodium chloride) Injection, 8.5% (8.5 g/100
mL), 102 mg/100 mL, 522 mg/100 mL, and 410 mg/100 mL..
Modicon 28 (ethinyl estradiol and norethindrone) Tablets, 0.035 mg/0.5 mg .....
NDA 017673 .............
NDA 017735 .............
NDA 017743 .............
jbell on DSKJLSW7X2PROD with NOTICES
approval of NDA 201655 for
reformulated OPANA ER (oxymorphone
hydrochloride) extended-release tablets,
and all amendments and supplements
thereto, is withdrawn under
§ 314.150(d). Distribution of
reformulated OPANA ER into interstate
commerce without an approved
application is illegal and subject to
regulatory action (see sections 505(a)
and 301(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(a) and
331(d)).
NDA 017789 .............
VerDate Sep<11>2014
Applicant
Brevicon 28-Day (ethinyl estradiol and norethindrone) Tablets, 0.035 mg/0.5
mg.
Aminosyn 3.5% (amino acids) Injection, 3.5% (3.5 g/100 mL).
Aminosyn 3.5% M (amino acids, magnesium acetate, phosphoric acid, potassium acetate, and sodium chloride) Injection, 3.5% (3.5 g/100 mL), 21 mg/
100 mL, 40 mg/100 mL, 128 mg/100 mL, and 234 mg/100 mL..
Aminosyn 3.5% M (amino acids, magnesium acetate, potassium acetate, and
sodium chloride) Injection, 3.5% (3.5 g/100 mL), 21 mg/100 mL, 128 mg/100
mL, and 234 mg/100 mL..
21:21 Dec 22, 2020
Jkt 253001
83973
PO 00000
Frm 00091
Fmt 4703
Sfmt 4703
E:\FR\FM\23DEN1.SGM
Hospira, Inc., 275 North Field Dr., Lake
Forest, IL 60045.
ICU Medical, Inc., 600 North Field Dr.,
Lake Forest, IL 60045.
Janssen Pharmaceuticals, Inc., 1125
Trenton-Harbourton Rd., Titusville,
NJ 08560.
Allergan Sales, LLC, 5 Giralda Farms,
Madison, NJ 07940.
23DEN1
83974
Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices
Application No.
Drug
NDA 018069 .............
Aminosyn 7% With Electrolytes (amino acids, magnesium chloride, potassium
phosphate dibasic, and sodium chloride) Injection, 7% (7 g/100 mL), 102
mg/100 mL, 410 mg/100 mL, and 522 mg/100 mL..
Vansil (oxamniquine) Capsules, 250 mg ..............................................................
NDA 018081 .............
Depakene (valproic acid) Capsules, 250 mg .......................................................
NDA 018281 .............
Tegretol (carbamazepine) Chewable Tablets, 100 mg ........................................
NDA 018429 .............
NDA 018704 .............
NDA 018876 .............
NDA 019029 .............
Aminosyn-RF 5.2% (amino acids) Injection, 5.2% (5.2 g/100 mL). .....................
Lopressor (metoprolol tartrate) Injection, 1 mg/mL ..............................................
Potassium Chloride 5 milliequivalent (mEq) in Dextrose 5% and Sodium Chloride 0.3% in Plastic Container (dextrose, potassium chloride, and sodium
chloride) Injection, 5 g/100 mL, 74.5 mg/100 mL, and 300 mg/100 mL.
Potassium Chloride 5 mEq in Dextrose 5% and Sodium Chloride 0.3% in Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5
g/100 mL, 149 mg/100 mL, and 300 mg/100 mL..
Potassium Chloride 10 mEq in Dextrose 5% and Sodium Chloride 0.3% in
Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 g/100 mL, 74.5 mg/100 mL, and 300 mg/mL..
Potassium Chloride 10 mEq in Dextrose 5% and Sodium Chloride 0.3% in
Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 g/100 mL, 149 mg/100 mL, and 300 mg/mL..
Potassium Chloride 15 mEq in Dextrose 5% and Sodium Chloride 0.3% in
Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 g/100 mL, 224 mg/100 mL, and 300 mg/100 mL..
Potassium Chloride 20 mEq in Dextrose 5% and Sodium Chloride 0.3% in
Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 g/100 mL, 298 mg/100 mL, and 300 mg/100 mL..
Potassium Chloride 20 mEq in Dextrose 5% in Sodium Chloride 0.3% in Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5
g/100 mL, 149 mg/100 mL, and 300 mg/100 mL..
Potassium Chloride 30 mEq in Dextrose 5% and Sodium Chloride 0.3% in
Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 g/100 mL, 224 mg/100 mL, and 300 mg/100 mL..
Potassium Chloride 40 mEq in Dextrose 5% and Sodium Chloride 0.3% in
Plastic Container (dextrose, potassium chloride, and sodium chloride) Injection, 5 g/100 mL, 298 mg/100 mL, and 300 mg/100 mL..
Ortho Novum 7/7/7 (ethinyl estradiol and norethindrone) (White) Tablets, 0.035
mg ethinyl estradiol and 0.5 mg norethindrone, (Light Peach) Tablets, 0.035
mg ethinyl estradiol and 0.75 mg norethindrone, (Peach) Tablets, 0.035 mg
ethinyl estradiol and 1 mg norethindrone.
Metronidazole Tablets, 250 mg ............................................................................
NDA 019374 .............
NDA 019435 .............
Aminosyn-HBC 7% (amino acids) Injection, 7% (7 g/100 mL). ...........................
Nix (permethrin) Topical Lotion, 1% .....................................................................
NDA 019437 .............
Aminosyn II M (amino acids, magnesium chloride, potassium chloride, sodium
chloride, and sodium phosphate dibasic heptahydrate) Injection, 3.5% (3.5 g/
100 mL), 30 mg/100 mL, 97 mg/100 mL, 120 mg/100 mL, and 49 mg/100
mL.
Aminosyn II With Electrolytes (amino acids, magnesium chloride, potassium
chloride, potassium phosphate dibasic, and sodium chloride) Injection, 7% (7
g/100 mL), 102 mg/100 mL, 45 mg/100 mL, 522 mg/100 mL, and 410 mg/
100 mL; 8.5% (8.5 g/100 mL), 102 mg/100 mL, 45 mg/100 mL, 522 mg/100
mL, and 410 mg/100 mL; and 10% (10 g/100 mL), 102 mg/100 mL, 45 mg/
100 mL, 522 mg/100 mL, and 410 mg/100 mL..
Aminosyn II With Electrolytes (amino acids, magnesium chloride, potassium
chloride, sodium chloride, and sodium phosphate dibasic) Injection, 8.5%
(8.5 g/100 mL), 102 mg/100 mL, 492 mg/100 mL, 60 mg/100 mL, and 425
mg/100 mL..
Aminosyn II 3.5% (amino acids) Injection, 3.5% (3.5 g/100 mL).
Aminosyn II 5% (amino acids) Injection, 5% (5 g/100 mL).
Aminosyn II 7% (amino acids) Injection, 7% (7 g/100 mL)..
Aminosyn II 8.5% (amino acids) Injection, 8.5% (8.5 g/100 mL)..
Aminosyn II 10% (amino acids) Injection, 10% (10 g/100 mL). ...........................
Ortho-Cyclen-21 (ethinyl estradiol and norgestimate) Oral-21 Tablets, 0.035
mg/0.250 mg.
Ortho Cyclen-28 (ethinyl estradiol and norgestimate) Oral-28 Tablets, 0.035
mg/0.25 mg..
Dextrose 50% in Plastic Container (dextrose) Injection, 50 g/100 mL ................
NDA 018985 .............
jbell on DSKJLSW7X2PROD with NOTICES
NDA 019438 .............
NDA 019653 .............
NDA 019894 .............
VerDate Sep<11>2014
21:21 Dec 22, 2020
Jkt 253001
PO 00000
Frm 00092
Fmt 4703
Applicant
Sfmt 4703
E:\FR\FM\23DEN1.SGM
ICU Medical, Inc.
Pfizer, Inc., 235 East 42nd St., New
York, NY 10017.
AbbVie, Inc., 1 North Waukegan Rd.,
North Chicago, IL 60064.
Novartis Pharmaceuticals Corp., 1
Health Plaza, East Hanover, NJ
07936.
ICU Medical, Inc.
Novartis Pharmaceuticals Corp.
Do.
Janssen Pharmaceuticals, Inc.
LNK International, Inc., 145 Ricefield
Lane, Hauppauge, NY 11788.
ICU Medical, Inc.
GlaxoSmithKline Consumer Healthcare
Holdings (US) LLC, 184 Liberty Corner Rd., suite 2000, Warren, NJ
07059.
Do.
Do.
Janssen Pharmaceuticals, Inc.
ICU Medical, Inc.
23DEN1
Federal Register / Vol. 85, No. 247 / Wednesday, December 23, 2020 / Notices
Application No.
NDA
NDA
NDA
NDA
019916
020593
020634
021241
.............
.............
.............
.............
NDA 206544 .............
NDA 208399 .............
Drug
Applicant
Morphine Sulfate Injection, 1 mg/mL and 5 mg/mL .............................................
Depacon (valproate sodium) Injection, Equivalent to (EQ) 100 mg base/mL ......
Levaquin (levofloxacin) Tablets, 250 mg, 500 mg, and 750 mg ..........................
Ortho Tri-Cyclen Lo (ethinyl estradiol and norgestimate) Oral-28 (White) Tablets, 0.025 mg ethinyl estradiol and 0.18 mg norgestimate; (Light Blue) Tablets, 0.025 mg ethinyl estradiol and 0.215 mg norgestimate; (Dark Blue) Tablets, 0.025 mg ethinyl estradiol and 0.250 mg norgestimate.
MorphaBond ER (morphine sulfate) Extended-Release Tablets, 15 mg, 30 mg,
60 mg, and 100 mg.
Varubi (rolapitant HCl) Injectable Emulsion, EQ 166.5 mg base/92.5 mL (EQ
1.8 mg base/mL).
NDA 209203 .............
Duzallo (allopurinol and lesinurad) Tablets, 200 mg/200 mg and 300 mg/200
mg.
NDA 210895 .............
Welchol (colesevelam HCl) Chewable Bars, 3.75 g ............................................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of January 22,
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 January 22,
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: December 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–28346 Filed 12–22–20; 8:45 am]
BILLING CODE 4164–01–P
revising the last sentence in the
‘‘Summary’’ section.
FOR FURTHER INFORMATION CONTACT:
Paige Ezernack, Office of the Assistant
Secretary for Preparedness and
Response, Office of Strategy, Policy,
Planning, and Requirements, Suite
5440—O’Neill House Office Building,
200 C Street SW, Washington, DC
20201, (202) 260–0365.
SUPPLEMENTARY INFORMATION:
I. Correction of Errors
In FR Doc. 2020–16458 of July 30,
2020 (85 FR 45895–45897), make the
following corrections:
On page 48596, first full column,
SUMMARY section, change second to last
sentence to ‘‘This notice, issued on July
23, 2020, extends the March 25
Designation Notice to January 19, 2021.’’
The expiration date, January 19, 2021 is
not 120 days from the date of issuance
so remove that reference.
Wilma Robinson,
Deputy Executive Secretary, Department of
Health and Human Services.
[FR Doc. 2020–28374 Filed 12–22–20; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
BILLING CODE 4150–28–P
Office of the Secretary
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Extension of Designation of Scarce
Materials or Threatened Materials
Subject to COVID–19 Hoarding
Prevention Measures; Correction of
Extension Date
Office of the Secretary (OS),
DHHS.
ACTION: Correction.
jbell on DSKJLSW7X2PROD with NOTICES
AGENCY:
SUMMARY: This document updates the
July 30, 2020, Federal Register Notice
entitled ‘‘Extension of Designation of
Scarce Materials or Threatened
Materials Subject to COVID–19
Hoarding Prevention Measures,’’ by
VerDate Sep<11>2014
21:21 Dec 22, 2020
Jkt 253001
National Institutes of Health
National Institute of Dental &
Craniofacial Research; Notice of
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the National Advisory Dental
and Craniofacial Research Council.
The meeting will be open to the
public via NIH videocast. The URL link
to this meeting is https://
videocast.nih.gov/watch=38984.
PO 00000
Frm 00093
Fmt 4703
83975
Sfmt 4703
Do.
AbbVie, Inc.
Janssen Pharmaceuticals, Inc.
Do.
Daiichi Sankyo, Inc., 211 Mount Airy
Rd., Basking Ridge, NJ 07920.
TerSera Therapeutics LLC, 520 Lake
Cook Rd., suite 500, Deerfield, IL
60015.
Ironwood Pharmaceuticals, Inc., 100
Summer St., suite 2300, Boston, MA
02110.
Daiichi Sankyo, Inc.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Dental and Craniofacial Research Council.
Date: January 27, 2021.
Open: 10:00 a.m. to 1:05 p.m.
Agenda: Report of the Director, NIDCR
Place: National Institute of Dental and
Craniofacial Research, National Institutes of
Health, 6701 Democracy Boulevard, Room
662 Bethesda, MD 20892, (Virtual Meeting).
Closed: 1:20 p.m. to 2:00 p.m.
Agenda: Grant applications.
Place: National Institute of Dental and
Craniofacial Research, National Institutes of
Health, 6701 Democracy Boulevard, Room
662 Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Alicia J. Dombroski, Ph.D.,
Director, Division of Extramural Activities,
National Institute of Dental and Craniofacial
Research, National Institutes of Health, 6701
Democracy Boulevard, Room 662, Bethesda,
MD 20892, 301–594–4805, adombroski@
nidcr.nih.gov.
Any interested person may file written
comments with the committee no later than
15 days after the meeting by forwarding the
statement to the Contact Person listed on this
notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
www.nidcr.nih.gov/about, where an agenda
and any additional information for the
meeting will be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.121, Oral Diseases and
Disorders Research, National Institutes of
Health, HHS)
E:\FR\FM\23DEN1.SGM
23DEN1
]]>Agencies
[Federal Register Volume 85, Number 247 (Wednesday, December 23, 2020)]
[Notices]
[Pages 83973-83975]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-28346]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-2272]
Hospira, Inc., et al.; Withdrawal of Approval of 27 New Drug
Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 27 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 January 22, 2021.
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.
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.
----------------------------------------------------------------------------------------------------------------
Application No. Drug Applicant
----------------------------------------------------------------------------------------------------------------
NDA 008809......................... M.V.I.-12 Adult (ascorbic acid, biotin,
cyanocobalamin, dexpanthenol, ergocalciferol,
folic acid, niacinamide, pyridoxine
hydrochloride (HCl), riboflavin 5'-phosphate
sodium, thiamine HCl, vitamin A, and vitamin
E) Injection, 10 milligrams (mg)/milliliters
(mL), 0.006 mg/mL, 0.5 micrograms (mcg)/mL,
1.5 mg/mL, 20 International Units (IU)/mL,
0.04 mg/mL, 4 mg/mL, 0.4 mg/mL, 0.36 mg/mL,
0.3 mg/mL, 330 Units/mL, and 1 IU/mL; and 20
mg/mL, 0.006 mg/mL, 0.05 mcg/mL, 1.5 mg/mL,
0.0005 mg/mL, 0.06 mg/mL, 4 mg/mL, 0.6 mg/mL,
0.36 mg/mL, 0.6 mg/mL, 0.1 mg/mL, and 1 mg/mL.
M.V.I.-12 Adult (ascorbic acid, biotin, Hospira, Inc., 275 North
cyanocobalamin, dexpanthenol, ergocalciferol, Field Dr., Lake Forest,
folic acid, niacinamide, pyridoxine HCl, IL 60045.
riboflavin, thiamine HCl, vitamin A, and
vitamin E) Injection, 20 mg/mL, 0.006 mg/mL,
0.5 mcg/mL, 1.5 mg/mL, 20 IU/mL, 0.6 mg/mL, 4
mg/mL, 0.4 mg/mL, 0.36 mg/mL, 0.6 mg/mL, 330
Units/mL, and 1 IU/mL..
NDA 017673......................... Aminosyn (amino acids) Injection, 5% (5 grams
(g)/100 mL), 7% (7 g/100 mL), 7% (pH6) (7 g/
100 mL), 8.5% (8.5 g/100 mL), 8.5% (pH6) (8.5
g/100 mL), 10% (10 g/100 mL), and 10% (pH6)
(10 g/100 mL).
Aminosyn 8.5% With Electrolytes (amino acids,
magnesium chloride, potassium chloride, sodium
chloride, and sodium phosphate dibasic)
Injection, 8.5% (8.5 g/100mL), 102 mg/100 mL,
487 mg/100 mL, 28 mg/100 mL, and 425 mg/100
mL..
Aminosyn 8.5% With Electrolytes (amino acids, ICU Medical, Inc., 600
magnesium chloride, potassium phosphate North Field Dr., Lake
dibasic, and sodium chloride) Injection, 8.5% Forest, IL 60045.
(8.5 g/100 mL), 102 mg/100 mL, 522 mg/100 mL,
and 410 mg/100 mL..
NDA 017735......................... Modicon 28 (ethinyl estradiol and Janssen Pharmaceuticals,
norethindrone) Tablets, 0.035 mg/0.5 mg. Inc., 1125 Trenton-
Harbourton Rd.,
Titusville, NJ 08560.
NDA 017743......................... Brevicon 28-Day (ethinyl estradiol and Allergan Sales, LLC, 5
norethindrone) Tablets, 0.035 mg/0.5 mg. Giralda Farms, Madison,
NJ 07940.
NDA 017789......................... Aminosyn 3.5% (amino acids) Injection, 3.5%
(3.5 g/100 mL).
Aminosyn 3.5% M (amino acids, magnesium
acetate, phosphoric acid, potassium acetate,
and sodium chloride) Injection, 3.5% (3.5 g/
100 mL), 21 mg/100 mL, 40 mg/100 mL, 128 mg/
100 mL, and 234 mg/100 mL..
Aminosyn 3.5% M (amino acids, magnesium
acetate, potassium acetate, and sodium
chloride) Injection, 3.5% (3.5 g/100 mL), 21
mg/100 mL, 128 mg/100 mL, and 234 mg/100 mL..
[[Page 83974]]
Aminosyn 7% With Electrolytes (amino acids, ICU Medical, Inc.
magnesium chloride, potassium phosphate
dibasic, and sodium chloride) Injection, 7% (7
g/100 mL), 102 mg/100 mL, 410 mg/100 mL, and
522 mg/100 mL..
NDA 018069......................... Vansil (oxamniquine) Capsules, 250 mg.......... Pfizer, Inc., 235 East
42nd St., New York, NY
10017.
NDA 018081......................... Depakene (valproic acid) Capsules, 250 mg...... AbbVie, Inc., 1 North
Waukegan Rd., North
Chicago, IL 60064.
NDA 018281......................... Tegretol (carbamazepine) Chewable Tablets, 100 Novartis Pharmaceuticals
mg. Corp., 1 Health Plaza,
East Hanover, NJ 07936.
NDA 018429......................... Aminosyn-RF 5.2% (amino acids) Injection, 5.2% ICU Medical, Inc.
(5.2 g/100 mL)..
NDA 018704......................... Lopressor (metoprolol tartrate) Injection, 1 mg/ Novartis Pharmaceuticals
mL. Corp.
NDA 018876......................... Potassium Chloride 5 milliequivalent (mEq) in
Dextrose 5% and Sodium Chloride 0.3% in
Plastic Container (dextrose, potassium
chloride, and sodium chloride) Injection, 5 g/
100 mL, 74.5 mg/100 mL, and 300 mg/100 mL.
Potassium Chloride 5 mEq in Dextrose 5% and
Sodium Chloride 0.3% in Plastic Container
(dextrose, potassium chloride, and sodium
chloride) Injection, 5 g/100 mL, 149 mg/100
mL, and 300 mg/100 mL..
Potassium Chloride 10 mEq in Dextrose 5% and
Sodium Chloride 0.3% in Plastic Container
(dextrose, potassium chloride, and sodium
chloride) Injection, 5 g/100 mL, 74.5 mg/100
mL, and 300 mg/mL..
Potassium Chloride 10 mEq in Dextrose 5% and
Sodium Chloride 0.3% in Plastic Container
(dextrose, potassium chloride, and sodium
chloride) Injection, 5 g/100 mL, 149 mg/100
mL, and 300 mg/mL..
Potassium Chloride 15 mEq in Dextrose 5% and
Sodium Chloride 0.3% in Plastic Container
(dextrose, potassium chloride, and sodium
chloride) Injection, 5 g/100 mL, 224 mg/100
mL, and 300 mg/100 mL..
Potassium Chloride 20 mEq in Dextrose 5% and
Sodium Chloride 0.3% in Plastic Container
(dextrose, potassium chloride, and sodium
chloride) Injection, 5 g/100 mL, 298 mg/100
mL, and 300 mg/100 mL..
Potassium Chloride 20 mEq in Dextrose 5% in
Sodium Chloride 0.3% in Plastic Container
(dextrose, potassium chloride, and sodium
chloride) Injection, 5 g/100 mL, 149 mg/100
mL, and 300 mg/100 mL..
Potassium Chloride 30 mEq in Dextrose 5% and
Sodium Chloride 0.3% in Plastic Container
(dextrose, potassium chloride, and sodium
chloride) Injection, 5 g/100 mL, 224 mg/100
mL, and 300 mg/100 mL..
Potassium Chloride 40 mEq in Dextrose 5% and Do.
Sodium Chloride 0.3% in Plastic Container
(dextrose, potassium chloride, and sodium
chloride) Injection, 5 g/100 mL, 298 mg/100
mL, and 300 mg/100 mL..
NDA 018985......................... Ortho Novum 7/7/7 (ethinyl estradiol and Janssen Pharmaceuticals,
norethindrone) (White) Tablets, 0.035 mg Inc.
ethinyl estradiol and 0.5 mg norethindrone,
(Light Peach) Tablets, 0.035 mg ethinyl
estradiol and 0.75 mg norethindrone, (Peach)
Tablets, 0.035 mg ethinyl estradiol and 1 mg
norethindrone.
NDA 019029......................... Metronidazole Tablets, 250 mg.................. LNK International, Inc.,
145 Ricefield Lane,
Hauppauge, NY 11788.
NDA 019374......................... Aminosyn-HBC 7% (amino acids) Injection, 7% (7 ICU Medical, Inc.
g/100 mL)..
NDA 019435......................... Nix (permethrin) Topical Lotion, 1%............ GlaxoSmithKline Consumer
Healthcare Holdings (US)
LLC, 184 Liberty Corner
Rd., suite 2000, Warren,
NJ 07059.
NDA 019437......................... Aminosyn II M (amino acids, magnesium chloride,
potassium chloride, sodium chloride, and
sodium phosphate dibasic heptahydrate)
Injection, 3.5% (3.5 g/100 mL), 30 mg/100 mL,
97 mg/100 mL, 120 mg/100 mL, and 49 mg/100 mL.
Aminosyn II With Electrolytes (amino acids,
magnesium chloride, potassium chloride,
potassium phosphate dibasic, and sodium
chloride) Injection, 7% (7 g/100 mL), 102 mg/
100 mL, 45 mg/100 mL, 522 mg/100 mL, and 410
mg/100 mL; 8.5% (8.5 g/100 mL), 102 mg/100 mL,
45 mg/100 mL, 522 mg/100 mL, and 410 mg/100
mL; and 10% (10 g/100 mL), 102 mg/100 mL, 45
mg/100 mL, 522 mg/100 mL, and 410 mg/100 mL..
Aminosyn II With Electrolytes (amino acids, Do.
magnesium chloride, potassium chloride, sodium
chloride, and sodium phosphate dibasic)
Injection, 8.5% (8.5 g/100 mL), 102 mg/100 mL,
492 mg/100 mL, 60 mg/100 mL, and 425 mg/100
mL..
NDA 019438......................... Aminosyn II 3.5% (amino acids) Injection, 3.5%
(3.5 g/100 mL).
Aminosyn II 5% (amino acids) Injection, 5% (5 g/
100 mL).
Aminosyn II 7% (amino acids) Injection, 7% (7 g/
100 mL)..
Aminosyn II 8.5% (amino acids) Injection, 8.5%
(8.5 g/100 mL)..
Aminosyn II 10% (amino acids) Injection, 10% Do.
(10 g/100 mL)..
NDA 019653......................... Ortho-Cyclen-21 (ethinyl estradiol and
norgestimate) Oral-21 Tablets, 0.035 mg/0.250
mg.
Ortho Cyclen-28 (ethinyl estradiol and Janssen Pharmaceuticals,
norgestimate) Oral-28 Tablets, 0.035 mg/0.25 Inc.
mg..
NDA 019894......................... Dextrose 50% in Plastic Container (dextrose) ICU Medical, Inc.
Injection, 50 g/100 mL.
[[Page 83975]]
NDA 019916......................... Morphine Sulfate Injection, 1 mg/mL and 5 mg/mL Do.
NDA 020593......................... Depacon (valproate sodium) Injection, AbbVie, Inc.
Equivalent to (EQ) 100 mg base/mL.
NDA 020634......................... Levaquin (levofloxacin) Tablets, 250 mg, 500 Janssen Pharmaceuticals,
mg, and 750 mg. Inc.
NDA 021241......................... Ortho Tri-Cyclen Lo (ethinyl estradiol and Do.
norgestimate) Oral-28 (White) Tablets, 0.025
mg ethinyl estradiol and 0.18 mg norgestimate;
(Light Blue) Tablets, 0.025 mg ethinyl
estradiol and 0.215 mg norgestimate; (Dark
Blue) Tablets, 0.025 mg ethinyl estradiol and
0.250 mg norgestimate.
NDA 206544......................... MorphaBond ER (morphine sulfate) Extended- Daiichi Sankyo, Inc., 211
Release Tablets, 15 mg, 30 mg, 60 mg, and 100 Mount Airy Rd., Basking
mg. Ridge, NJ 07920.
NDA 208399......................... Varubi (rolapitant HCl) Injectable Emulsion, EQ TerSera Therapeutics LLC,
166.5 mg base/92.5 mL (EQ 1.8 mg base/mL). 520 Lake Cook Rd., suite
500, Deerfield, IL 60015.
NDA 209203......................... Duzallo (allopurinol and lesinurad) Tablets, Ironwood Pharmaceuticals,
200 mg/200 mg and 300 mg/200 mg. Inc., 100 Summer St.,
suite 2300, Boston, MA
02110.
NDA 210895......................... Welchol (colesevelam HCl) Chewable Bars, 3.75 g Daiichi Sankyo, Inc.
----------------------------------------------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
January 22, 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 January 22, 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: December 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-28346 Filed 12-22-20; 8:45 am]
BILLING CODE 4164-01-P
