Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of 7 New Drug Applications and 71 Abbreviated New Drug Applications, 46079-46081 [2017-21177]
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Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
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asabaliauskas on DSKBBXCHB2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Norman R.
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and Research, Food and Drug
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MD 20993–0002, Norman.Schmuff@
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796–4548.
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
16:49 Oct 02, 2017
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I. Background
In recent years, many important
initiatives have been undertaken by
regulatory authorities and industry
associations to promote international
harmonization of regulatory
requirements. FDA has participated in
many meetings designed to enhance
harmonization and is committed to
seeking scientifically-based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify and then
reduce differences in technical
requirements for drug development
among regulatory agencies.
ICH was organized to provide an
opportunity for harmonization
initiatives to be developed with input
from both regulatory and industry
representatives. FDA also seeks input
from consumer representatives and
others. ICH is concerned with
harmonization of technical
requirements for the registration of
pharmaceutical products for human use
among regulators around the world. The
six founding members of the ICH are the
European Commission; the European
Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of
Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers
Association; CDER and CBER, FDA; and
the Pharmaceutical Research and
Manufacturers of America. The
Standing Members of the ICH
Association include Health Canada and
Swissmedic. Any party eligible as a
member in accordance with the ICH
Articles of Association can apply for
membership in writing to the ICH
Secretariat. The ICH Secretariat, which
coordinates the preparation of
documentation, operates as an
international nonprofit organization and
is funded by the members of the ICH
Association.
The ICH Assembly is the overarching
body of the Association and includes
representatives from each of the ICH
members and observers.
The M4 guidance provides guidance
on the organization of the CTD and
eCTD for Modules 2 through 5
providing direction on the location and
hierarchy of headings within modules,
document pagination and segregation,
section numbering within documents,
and the formatting of the table of
contents. The guidance updates the
Quality-related sections of the
Granularity Document Annex, Module
2.3 Quality Overall Summary, and
Module 3 Quality. The guidance
provides separate tables describing the
recommended granularity for paper and
eCTD v3.2.2 submissions, and for paper
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46079
and eCTD v4 submissions, and includes
‘‘Appendices for eCTD v4 Submissions’’
to facilitate the implementation of the
next major version of the eCTD. This
guidance replaces both the August 2001
FDA GIF ‘‘M4: Organization of the CTD’’
and the October 2005 FDA GIF
‘‘Granularity Document Annex to M4:
Organization of the CTD.’’ This merger
reflects the 2002 addition of the Annex:
Granularity Document into the ‘‘M4
Organization of the Common Technical
Document for the Registration of
Pharmaceuticals for Human Use.’’
There have been no updates or
changes relative to Module 4 or Module
5.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the organization of
the CTD for the registration of
pharmaceuticals for human use. It does
not establish any rights for any person
and is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Electronic Access
Persons with access to the internet
may obtain the document at https://
www.regulations.gov, https://
www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, or https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm.
Dated: September 28, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–21229 Filed 10–2–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4563]
Johnson & Johnson Consumer Inc. et
al.; Withdrawal of Approval of 7 New
Drug Applications and 71 Abbreviated
New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is withdrawing
approval of 7 new drug applications
(NDAs) and 71 abbreviated new drug
applications (ANDAs) from multiple
SUMMARY:
E:\FR\FM\03OCN1.SGM
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Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
applicants. The holders of the
applications notified the Agency in
writing that the drug products were no
longer marketed and requested that the
approval of the applications be
withdrawn.
DATES: Withdrawal of approval is
effective November 2, 2017.
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
The
holders of the applications listed in the
table have informed FDA that these drug
products are no longer marketed and
have requested that FDA withdraw
SUPPLEMENTARY INFORMATION:
approval of the applications pursuant to
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.
Application No.
Drug
Applicant
NDA 014349 ...........................
Delfen (nonoxynol-9) Contraceptive Foam, 12.5% ............
ANDA 019346 .........................
Dextrose 60% Injection USP in Plastic Container ..............
NDA 019810 ...........................
Prilosec (omeprazole) Delayed-Release Capsules, 10 milligrams (mg), 20 mg, and 40 mg.
Aceon (perindopril erbumine) Tablets, 2 mg, 4 mg, and 8
mg.
Potiga (ezogabine) Tablets, 50 mg, 200 mg, 300 mg, and
400 mg.
Johnson & Johnson Consumer Inc., 199 Grandview Rd., Skillman, NJ
08558.
Hospira, Inc., 275 North Field Dr., Dept. 389, Bldg. H2–2, Lake Forest,
IL 60045.
AstraZeneca Pharmaceuticals LP, One MedImmune Way, Gaithersburg,
MD 20878.
Symplmed Pharmaceuticals, LLC, 5375 Medspace Way, Cincinnati, OH
45227.
GlaxoSmithKline Intellectual Property Management LTD England, c/o
GlaxoSmithKline, 1250 South Collegeville Road, P.O. Box 5089,
Collegeville, PA 19426.
UCB, Inc., 1950 Lake Park Dr., Bldg. 2100, Smyrna, GA 30080.
NDA 020184 ...........................
NDA 022345 ...........................
NDA 021712 ...........................
ANDA 040108 .........................
ANDA 040206 .........................
ANDA 040527 .........................
ANDA 040899 .........................
ANDA 060099 .........................
ANDA 063161 .........................
ANDA 070171 .........................
ANDA 070186 .........................
ANDA 070233 .........................
ANDA 070255 .........................
ANDA 070698 .........................
ANDA 070699 .........................
ANDA 070739 .........................
ANDA 070740 .........................
ANDA 070803 .........................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
070888
071357
071438
071618
071619
071982
.........................
.........................
.........................
.........................
.........................
.........................
ANDA 072321 .........................
ANDA 073199 .........................
ANDA 073310 .........................
ANDA 073428 .........................
ANDA 073433 .........................
ANDA 073677 .........................
ANDA 074168 .........................
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ANDA 074280 .........................
ANDA 074296 .........................
ANDA 074412 .........................
ANDA 074422 .........................
ANDA 074468 .........................
ANDA 074620 .........................
ANDA 074758 .........................
VerDate Sep<11>2014
Fluxid (famotidine) Orally Disintegrating Tablets, 20 mg
and 40 mg.
Acetazolamide for Injection USP, Equivalent to (EQ) 500
mg base/vial.
Digoxin Injection USP, 0.25 mg/milliliter (mL) ....................
Phentermine Hydrochloride (HCl) Capsules USP, 37.5 mg
Hydroxyzine HCl Tablets USP, 10 mg, 25 mg, and 50 mg
Penicillin G Procaine for Injection, 300,000 units/vial and
1,500,000 units/vial.
Tobramycin Injection USP, EQ 40 mg base/mL ................
Naloxone HCl Injection USP, 0.02 mg/mL .........................
Disopyramide Phosphate Capsules USP, EQ 100 mg
base.
Propranolol HCl Tablets USP, 20 mg .................................
Naloxone HCl Injection, 0.4 mg/mL ....................................
Methyldopate HCl Injection USP, 50 mg/mL, ADD-Vantage Vial.
Methyldopate HCl Injection USP, 50 mg/mL, Fliptop Vial ..
Verapamil HCl Injection, 2.5 mg/mL, 2 mL Abbojet-PA Syringe.
Verapamil HCl Injection, 2.5 mg/mL, 4 mL Abbojet Syringe Vial.
Enflurane USP, 99.9% ........................................................
Aminocaproic Acid Injection USP, 250 mg/mL ...................
Tolazamide Tablets USP, 100 mg ......................................
Ritodrine HCl in Dextrose 5% Injection, 30 mg/100 mL ....
Ritodrine HCl Injection USP, 10 mg/mL .............................
Ritodrine HCl Injection USP, 15 mg/mL .............................
Droperidol and Fentanyl Citrate Injection, 2.5 mg/mL and
EQ 0.05 mg base/mL.
Pancuronium Bromide Injection, 2 mg/mL .........................
Sulfamethoxazole and Trimethoprim Injection USP, 80
mg/mL and 16 mg/mL.
Tolmetin Sodium Tablets USP, EQ 200 mg base ..............
CO–LAV (polyethylene glycol 3350 and electrolytes) for
Oral Suspension.
GO–EVAC (polyethylene glycol 3350 and electrolytes) for
Oral Suspension.
Carbastat (carbachol) Intraocular Solution, 0.01% .............
Diltiazem HCl Tablets USP, 30 mg, 60 mg, 90 mg, and
120 mg.
Lorazepam Injection USP, 2 mg/mL and 4 mg/mL ............
Cimetidine HCl Injection, EQ 300 mg base/2 mL
(Carpuject).
Cimetidine HCl Injection, EQ 300 mg base/2 mL ..............
Cimetidine HCl Injection, EQ 300 mg base/2 mL, ADDVantage Vial.
Cimetidine HCl in Sodium Chloride 0.9% Injection in Plastic Container, EQ 90 mg base/100 mL, EQ 120 mg
base/100 mL, EQ 180 mg base/100 mL, EQ 240 mg
base/100 mL, EQ 360 mg/100 mL, and EQ 480 mg
base/100 mL.
Butorphanol Tartrate Injection USP, 1 mg/mL and 2 mg/
mL.
Acyclovir for Injection USP, EQ 500 mg base/vial and EQ
1 gram (g) base/vial.
16:49 Oct 02, 2017
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Hospira, Inc.
Do.
Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd., Cranbury,
NJ 08512.
Do.
Pfizer Inc., 235 East 42nd St., New York, NY 10017.
Hospira, Inc.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA,
Inc., 425 Privet Rd., Horsham, PA 19044.
Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Hospira, Inc.
Do.
Do.
Do.
Do.
Abbott Laboratories, Hospital Products Division, 200 Abbott Park Rd.,
D389, Bldg. J45–2, Abbott Park, IL 60064.
Hospira, Inc.
Sun Pharmaceutical Industries, Inc.
Hospira, Inc.
Do.
Do.
Do.
Do.
Do.
Sun Pharmaceutical Industries, Inc.
Vintage Pharmaceuticals, 150 Vintage Dr., Huntsville, AL 35811.
Do.
Novartis Pharmaceuticals Corp., One Health Plaza, East Hanover, NJ
07936.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA,
Inc.
Hospira, Inc.
Do.
Sfmt 4703
Do.
Do.
Do.
Do.
Do.
E:\FR\FM\03OCN1.SGM
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Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices
Application No.
Drug
ANDA 074801 .........................
Ketorolac Tromethamine Injection USP, 15 mg/mL and 30
mg/mL.
Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mg .....
ANDA 075385 .........................
ANDA 075453 .........................
ANDA 076883 .........................
ANDA 077052 .........................
ANDA 077937 .........................
ANDA 078081 .........................
ANDA 078158 .........................
ANDA 078483 .........................
ANDA 080136 .........................
ANDA 080209 .........................
ANDA 080224 .........................
ANDA 083345 .........................
ANDA 083808 .........................
ANDA 084623 .........................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
084644
084710
085061
085933
086494
086821
087416
087546
087862
088147
.........................
.........................
.........................
.........................
.........................
.........................
.........................
.........................
.........................
.........................
ANDA 088367 .........................
ANDA 088542 .........................
ANDA 089162 .........................
ANDA 089347 .........................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
089393
089488
089521
089537
089744
089915
.........................
.........................
.........................
.........................
.........................
.........................
NDA 202258 ...........................
asabaliauskas on DSKBBXCHB2PROD with NOTICES
NDA 203093 ...........................
Applicant
Doxazosin Tablets USP, EQ 1 mg base, EQ 2 mg base,
EQ 4 mg base, and EQ 8 mg base.
Sotalol HCl Tablets USP, 80 mg, 120 mg, and 160 mg ....
Citalopram Hydrobromide Tablets, EQ 10 mg base, EQ
20 mg base, and EQ 40 mg base.
Meloxicam Tablets, 7.5 mg and 15 mg ..............................
Amlodipine Besylate Tablets, EQ 2.5 mg base, EQ 5 mg
base, and EQ 10 mg base.
Fosphenytoin Sodium Injection USP, EQ 50 mg Phenytoin Soudium/mL.
Zolpidem Tartrate Extended-Release Tablets USP, 6.25
mg and 12.5 mg.
Isoniazid Tablets, 100 mg ...................................................
Prednisone Tablets USP, 5 mg ..........................................
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA,
Inc.
Do.
Teva Pharmaceuticals USA, Inc.
Sun Pharmaceutical Industries, Inc.
Do.
Do.
Hospira, Inc.
Synthon Pharmaceuticals, Inc., 1007 Slater Rd., Suite 150, Durham, NC
27703.
Sun Pharmaceutical Industries, Inc.
Contract Pharmacal Corp., c/o SciRegs International Inc., 6333
Summercrest Dr., Columbia, MD 21045.
Hospira, Inc.
Sorbitol; Mannitol Irrigation Solution, 2.7 g/100 mL; 540
mg/100 mL.
Potassium Chloride for Injection Concentrate USP, 1
Do.
milliequivalent (mEQ)/mL, 1.5 mEQ/mL, and 2 mEQ/mL.
Quinidine Sulfate Tablets USP, 200 mg ............................. Contract Pharmacal Corp., c/o SciRegs International Inc.
Chlordiazepoxide HCl Capsules USP, 10 mg .................... Upsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN
55369.
Chlordiazepoxide HCl Capsules USP, 5 mg ......................
Do.
Ogen (estropipate) Vaginal Cream USP, 1.5 mg/g ............ Pfizer Inc.
Folic Acid Tablets USP, 1 mg ............................................ Contract Pharmacal Corp., c/o SciRegs International Inc.
Phentermine HCl Tablets USP ........................................... Lemmon Co., 650 Cathill Rd., Sellersville, PA 18960.
Chlordiazepoxide HCl Capsules, 25 mg ............................. Teva Pharmaceuticals USA, Inc.
Hydroxyzine HCl Injection USP, 50 mg/mL ........................ Hospira, Inc.
Hydroxyzine HCl Injection USP, 25 mg/mL, Carpuject ......
Do.
Hydroxyzine HCl Injection USP, 50 mg/mL, Carpuject ......
Do.
Hydroxyzine HCl Tablets USP, 100 mg ............................. Sun Pharmaceutical Industries, Inc.
Aminophylline in Sodium Chloride 0.45% Injection, 100 Hospira, Inc.
mg/100 mL and 200 mg/100 mL.
Lidocaine HCl Injection USP, 10% .....................................
Do.
Lidocaine HCl Injection USP, 4% .......................................
Do.
Cyclopentolate HCl Ophthalmic Solution, 1% .................... Alcon Pharmaceuticals, Ltd., 6201 South Freeway TC–45, Fort Worth,
TX 76134.
Diatrizoate Meglumine and Diatrizoate Sodium Injection Bracco Diagnostics Inc., 259 Prospect Plains Rd., Bldg. H, Monroe
USP, 66%; 10%.
Township, NJ 08831.
Glycopyrrolate Injection USP, 0.2 mg/mL .......................... Hospira, Inc.
Diphenhydramine HCl Capsules, 25 mg ............................ Sun Pharmaceutical Industries, Inc.
Phenytoin Sodium Injection USP, 50 mg/mL, Ampule ....... Hospira, Inc.
Procainamide HCl Injection USP, 500 mg/mL, Carpuject ..
Do.
Phenytoin Sodium Injection USP, 50 mg/mL, Carpuject ....
Do.
Leucovorin Calcium for Injection, EQ 100 mg base/vial .... Pharmachemie B.V., c/o SICOR Pharmaceuticals, Inc., 19 Hughes,
Irvine, CA 92618.
Victrelis (boceprevir) Capsules, 200 mg ............................. Merck Sharp & Dohme Corp., Subsidiary of Merck & Company, Inc., 1
Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889.
Vitekta (elvitegravir) Tablets, 85 mg and 150 mg .............. Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404.
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn, effective
November 2, 2017. 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 the date that this
notice becomes effective (see DATES)
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.
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46081
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Dated: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[FR Doc. 2017–21177 Filed 10–2–17; 8:45 am]
[Docket No. FDA–2017–N–4977]
BILLING CODE 4164–01–P
PO 00000
Food and Drug Administration
Joint Meeting of the
Psychopharmacologic Drugs Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice; establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA or Agency)
announces a forthcoming public
SUMMARY:
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]]>Agencies
[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46079-46081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21177]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-4563]
Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of
7 New Drug Applications and 71 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 7 new drug applications (NDAs) and 71 abbreviated new drug
applications (ANDAs) from multiple
[[Page 46080]]
applicants. The holders of the applications notified the Agency in
writing that the drug products were no longer marketed and requested
that the approval of the applications be withdrawn.
DATES: Withdrawal of approval is effective November 2, 2017.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications 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 pursuant to 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 014349.............................. Delfen (nonoxynol-9) Johnson & Johnson Consumer Inc., 199
Contraceptive Foam, 12.5%. Grandview Rd., Skillman, NJ 08558.
ANDA 019346............................. Dextrose 60% Injection USP in Hospira, Inc., 275 North Field Dr.,
Plastic Container. Dept. 389, Bldg. H2-2, Lake Forest,
IL 60045.
NDA 019810.............................. Prilosec (omeprazole) Delayed- AstraZeneca Pharmaceuticals LP, One
Release Capsules, 10 milligrams MedImmune Way, Gaithersburg, MD
(mg), 20 mg, and 40 mg. 20878.
NDA 020184.............................. Aceon (perindopril erbumine) Symplmed Pharmaceuticals, LLC, 5375
Tablets, 2 mg, 4 mg, and 8 mg. Medspace Way, Cincinnati, OH 45227.
NDA 022345.............................. Potiga (ezogabine) Tablets, 50 GlaxoSmithKline Intellectual
mg, 200 mg, 300 mg, and 400 mg. Property Management LTD England, c/
o GlaxoSmithKline, 1250 South
Collegeville Road, P.O. Box 5089,
Collegeville, PA 19426.
NDA 021712.............................. Fluxid (famotidine) Orally UCB, Inc., 1950 Lake Park Dr., Bldg.
Disintegrating Tablets, 20 mg 2100, Smyrna, GA 30080.
and 40 mg.
ANDA 040108............................. Acetazolamide for Injection USP, Hospira, Inc.
Equivalent to (EQ) 500 mg base/
vial.
ANDA 040206............................. Digoxin Injection USP, 0.25 mg/ Do.
milliliter (mL).
ANDA 040527............................. Phentermine Hydrochloride (HCl) Sun Pharmaceutical Industries, Inc.,
Capsules USP, 37.5 mg. 270 Prospect Plains Rd., Cranbury,
NJ 08512.
ANDA 040899............................. Hydroxyzine HCl Tablets USP, 10 Do.
mg, 25 mg, and 50 mg.
ANDA 060099............................. Penicillin G Procaine for Pfizer Inc., 235 East 42nd St., New
Injection, 300,000 units/vial York, NY 10017.
and 1,500,000 units/vial.
ANDA 063161............................. Tobramycin Injection USP, EQ 40 Hospira, Inc.
mg base/mL.
ANDA 070171............................. Naloxone HCl Injection USP, 0.02 Do.
mg/mL.
ANDA 070186............................. Disopyramide Phosphate Capsules Ivax Pharmaceuticals, Inc.,
USP, EQ 100 mg base. Subsidiary of Teva Pharmaceuticals
USA, Inc., 425 Privet Rd., Horsham,
PA 19044.
ANDA 070233............................. Propranolol HCl Tablets USP, 20 Teva Pharmaceuticals USA, Inc., 425
mg. Privet Rd., Horsham, PA 19044.
ANDA 070255............................. Naloxone HCl Injection, 0.4 mg/ Hospira, Inc.
mL.
ANDA 070698............................. Methyldopate HCl Injection USP, Do.
50 mg/mL, ADD-Vantage Vial.
ANDA 070699............................. Methyldopate HCl Injection USP, Do.
50 mg/mL, Fliptop Vial.
ANDA 070739............................. Verapamil HCl Injection, 2.5 mg/ Do.
mL, 2 mL Abbojet-PA Syringe.
ANDA 070740............................. Verapamil HCl Injection, 2.5 mg/ Do.
mL, 4 mL Abbojet Syringe Vial.
ANDA 070803............................. Enflurane USP, 99.9%............ Abbott Laboratories, Hospital
Products Division, 200 Abbott Park
Rd., D389, Bldg. J45-2, Abbott
Park, IL 60064.
ANDA 070888............................. Aminocaproic Acid Injection USP, Hospira, Inc.
250 mg/mL.
ANDA 071357............................. Tolazamide Tablets USP, 100 mg.. Sun Pharmaceutical Industries, Inc.
ANDA 071438............................. Ritodrine HCl in Dextrose 5% Hospira, Inc.
Injection, 30 mg/100 mL.
ANDA 071618............................. Ritodrine HCl Injection USP, 10 Do.
mg/mL.
ANDA 071619............................. Ritodrine HCl Injection USP, 15 Do.
mg/mL.
ANDA 071982............................. Droperidol and Fentanyl Citrate Do.
Injection, 2.5 mg/mL and EQ
0.05 mg base/mL.
ANDA 072321............................. Pancuronium Bromide Injection, 2 Do.
mg/mL.
ANDA 073199............................. Sulfamethoxazole and Do.
Trimethoprim Injection USP, 80
mg/mL and 16 mg/mL.
ANDA 073310............................. Tolmetin Sodium Tablets USP, EQ Sun Pharmaceutical Industries, Inc.
200 mg base.
ANDA 073428............................. CO-LAV (polyethylene glycol 3350 Vintage Pharmaceuticals, 150 Vintage
and electrolytes) for Oral Dr., Huntsville, AL 35811.
Suspension.
ANDA 073433............................. GO-EVAC (polyethylene glycol Do.
3350 and electrolytes) for Oral
Suspension.
ANDA 073677............................. Carbastat (carbachol) Novartis Pharmaceuticals Corp., One
Intraocular Solution, 0.01%. Health Plaza, East Hanover, NJ
07936.
ANDA 074168............................. Diltiazem HCl Tablets USP, 30 Ivax Pharmaceuticals, Inc.,
mg, 60 mg, 90 mg, and 120 mg. Subsidiary of Teva Pharmaceuticals
USA, Inc.
ANDA 074280............................. Lorazepam Injection USP, 2 mg/mL Hospira, Inc.
and 4 mg/mL.
ANDA 074296............................. Cimetidine HCl Injection, EQ 300 Do.
mg base/2 mL (Carpuject).
ANDA 074412............................. Cimetidine HCl Injection, EQ 300 Do.
mg base/2 mL.
ANDA 074422............................. Cimetidine HCl Injection, EQ 300 Do.
mg base/2 mL, ADD-Vantage Vial.
ANDA 074468............................. Cimetidine HCl in Sodium Do.
Chloride 0.9% Injection in
Plastic Container, EQ 90 mg
base/100 mL, EQ 120 mg base/100
mL, EQ 180 mg base/100 mL, EQ
240 mg base/100 mL, EQ 360 mg/
100 mL, and EQ 480 mg base/100
mL.
ANDA 074620............................. Butorphanol Tartrate Injection Do.
USP, 1 mg/mL and 2 mg/mL.
ANDA 074758............................. Acyclovir for Injection USP, EQ Do.
500 mg base/vial and EQ 1 gram
(g) base/vial.
[[Page 46081]]
ANDA 074801............................. Ketorolac Tromethamine Injection Do.
USP, 15 mg/mL and 30 mg/mL.
ANDA 075385............................. Buspirone HCl Tablets USP, 5 mg, Ivax Pharmaceuticals, Inc.,
10 mg, and 15 mg. Subsidiary of Teva Pharmaceuticals
USA, Inc.
ANDA 075453............................. Doxazosin Tablets USP, EQ 1 mg Do.
base, EQ 2 mg base, EQ 4 mg
base, and EQ 8 mg base.
ANDA 076883............................. Sotalol HCl Tablets USP, 80 mg, Teva Pharmaceuticals USA, Inc.
120 mg, and 160 mg.
ANDA 077052............................. Citalopram Hydrobromide Tablets, Sun Pharmaceutical Industries, Inc.
EQ 10 mg base, EQ 20 mg base,
and EQ 40 mg base.
ANDA 077937............................. Meloxicam Tablets, 7.5 mg and 15 Do.
mg.
ANDA 078081............................. Amlodipine Besylate Tablets, EQ Do.
2.5 mg base, EQ 5 mg base, and
EQ 10 mg base.
ANDA 078158............................. Fosphenytoin Sodium Injection Hospira, Inc.
USP, EQ 50 mg Phenytoin Soudium/
mL.
ANDA 078483............................. Zolpidem Tartrate Extended- Synthon Pharmaceuticals, Inc., 1007
Release Tablets USP, 6.25 mg Slater Rd., Suite 150, Durham, NC
and 12.5 mg. 27703.
ANDA 080136............................. Isoniazid Tablets, 100 mg....... Sun Pharmaceutical Industries, Inc.
ANDA 080209............................. Prednisone Tablets USP, 5 mg.... Contract Pharmacal Corp., c/o
SciRegs International Inc., 6333
Summercrest Dr., Columbia, MD
21045.
ANDA 080224............................. Sorbitol; Mannitol Irrigation Hospira, Inc.
Solution, 2.7 g/100 mL; 540 mg/
100 mL.
ANDA 083345............................. Potassium Chloride for Injection Do.
Concentrate USP, 1
milliequivalent (mEQ)/mL, 1.5
mEQ/mL, and 2 mEQ/mL.
ANDA 083808............................. Quinidine Sulfate Tablets USP, Contract Pharmacal Corp., c/o
200 mg. SciRegs International Inc.
ANDA 084623............................. Chlordiazepoxide HCl Capsules Upsher-Smith Laboratories, Inc.,
USP, 10 mg. 6701 Evenstad Dr., Maple Grove, MN
55369.
ANDA 084644............................. Chlordiazepoxide HCl Capsules Do.
USP, 5 mg.
ANDA 084710............................. Ogen (estropipate) Vaginal Cream Pfizer Inc.
USP, 1.5 mg/g.
ANDA 085061............................. Folic Acid Tablets USP, 1 mg.... Contract Pharmacal Corp., c/o
SciRegs International Inc.
ANDA 085933............................. Phentermine HCl Tablets USP..... Lemmon Co., 650 Cathill Rd.,
Sellersville, PA 18960.
ANDA 086494............................. Chlordiazepoxide HCl Capsules, Teva Pharmaceuticals USA, Inc.
25 mg.
ANDA 086821............................. Hydroxyzine HCl Injection USP, Hospira, Inc.
50 mg/mL.
ANDA 087416............................. Hydroxyzine HCl Injection USP, Do.
25 mg/mL, Carpuject.
ANDA 087546............................. Hydroxyzine HCl Injection USP, Do.
50 mg/mL, Carpuject.
ANDA 087862............................. Hydroxyzine HCl Tablets USP, 100 Sun Pharmaceutical Industries, Inc.
mg.
ANDA 088147............................. Aminophylline in Sodium Chloride Hospira, Inc.
0.45% Injection, 100 mg/100 mL
and 200 mg/100 mL.
ANDA 088367............................. Lidocaine HCl Injection USP, 10% Do.
ANDA 088542............................. Lidocaine HCl Injection USP, 4%. Do.
ANDA 089162............................. Cyclopentolate HCl Ophthalmic Alcon Pharmaceuticals, Ltd., 6201
Solution, 1%. South Freeway TC-45, Fort Worth, TX
76134.
ANDA 089347............................. Diatrizoate Meglumine and Bracco Diagnostics Inc., 259
Diatrizoate Sodium Injection Prospect Plains Rd., Bldg. H,
USP, 66%; 10%. Monroe Township, NJ 08831.
ANDA 089393............................. Glycopyrrolate Injection USP, Hospira, Inc.
0.2 mg/mL.
ANDA 089488............................. Diphenhydramine HCl Capsules, 25 Sun Pharmaceutical Industries, Inc.
mg.
ANDA 089521............................. Phenytoin Sodium Injection USP, Hospira, Inc.
50 mg/mL, Ampule.
ANDA 089537............................. Procainamide HCl Injection USP, Do.
500 mg/mL, Carpuject.
ANDA 089744............................. Phenytoin Sodium Injection USP, Do.
50 mg/mL, Carpuject.
ANDA 089915............................. Leucovorin Calcium for Pharmachemie B.V., c/o SICOR
Injection, EQ 100 mg base/vial. Pharmaceuticals, Inc., 19 Hughes,
Irvine, CA 92618.
NDA 202258.............................. Victrelis (boceprevir) Capsules, Merck Sharp & Dohme Corp.,
200 mg. Subsidiary of Merck & Company,
Inc., 1 Merck Dr., P.O. Box 100,
Whitehouse Station, NJ 08889.
NDA 203093.............................. Vitekta (elvitegravir) Tablets, Gilead Sciences, Inc., 333 Lakeside
85 mg and 150 mg. Dr., Foster City, CA 94404.
----------------------------------------------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn, effective
November 2, 2017. 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 the date that this notice becomes
effective (see DATES) 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: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21177 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P
