[Federal Register Volume 83, Number 134 (Thursday, July 12, 2018)]
[Notices]
[Pages 32305-32306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14935]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2180]
Concordia Pharmaceuticals, Inc., et al.; Withdrawal of Approval
of 29 New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 29 new drug applications (NDAs) from multiple
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that the approval of the applications be withdrawn.
DATES: Approval is withdrawn as of August 13, 2018.
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 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.
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Application No. Drug Applicant
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NDA 011287............. Kayexalate (sodium Concordia
polystyrene sulfonate) Pharmaceuticals,
Powder for Suspension, Inc., c/o Mapi USA,
453.6 gram (g)/bottle. Inc., 2343 Alexandria
Dr., Lexington, KY
40504.
NDA 012249............. Librium Valeant
(chlordiazepoxide Pharmaceuticals North
hydrochloride (HCl)) America, LLC, 400
Capsules, 5 milligram Somerset Corporate
(mg), 10 mg, and 25 mg. Blvd., Bridgewater,
NJ 08807.
NDA 016211............. Miochol (acetylcholine Novartis
chloride) for Pharmaceuticals
Ophthalmic Solution, Corp., One Health
20 mg/vial. Pl., East Hanover, NJ
07936.
NDA 018674............. Metro I.V. B. Braun Medical,
(metronidazole) Inc., 901 Marcon
Injection, 500 mg/100 Blvd., Allentown, PA
milliliter (mL). 18109.
NDA 018852............. Sulfamethoxazole and Watson Laboratories,
Trimethoprim Tablets Inc., Subsidiary of
USP, 400 mg; 80 mg. Teva Pharmaceuticals
USA, Inc., 425 Privet
Rd., Horsham, PA
19044.
NDA 018854............. Sulfamethoxazole and Do.
Trimethoprim Tablets
USP, 800 mg; 160 mg.
NDA 018988............. Vasocidin (prednisolone Novartis
sodium phosphate and Pharmaceuticals Corp.
sulfacetamide sodium)
Ophthalmic Solution,
equivalent to (EQ)
0.23% phosphate/10%.
NDA 019844............. Isolyte H in Dextrose B. Braun Medical, Inc.
5% in Plastic
Container Injection.
NDA 019870............. Isolyte M in Dextrose Do.
5% in Plastic
Container Injection.
NDA 019964............. Terazol 3 (terconazole) Janssen
Vaginal Cream, 0.8%. Pharmaceuticals,
Inc., 1125 Trenton-
Harbourton Rd.,
Titusville, NJ 08560.
NDA 020000............. Dextrose 5% in Ringer's B. Braun Medical, Inc.
in Plastic Container
Injection.
NDA 020393............. Atrovent (ipratropium Boehringer Ingelheim
bromide) Nasal Spray, Pharmaceuticals,
0.021 mg/spray. Inc., 900 Ridgebury
Rd., P.O. Box 368,
Ridgefield, CT 06877-
0368.
NDA 020394............. Atrovent (ipratropium Do.
bromide) Nasal Spray,
0.042 mg/spray.
NDA 021180............. Ortho Evra (ethinyl Janssen
estradiol; Pharmaceuticals,
norelgestromin) Inc., 1000 U.S. Route
Transdermal Patch, 202, P.O. Box 300,
0.035 mg/24 h; 0.15 mg/ Raritan, NJ 08869-
24 h. 0602.
NDA 021633............. Femtrace (estradiol Allergan
acetate) Tablets, 0.45 Pharmaceuticals
mg, 0.9 mg, and 1.8 mg. International, Ltd.,
c/o Allergan Sales,
LLC, 2525 Dupont Dr.,
Irvine, CA 92612.
NDA 022033............. Luvox CR (fluvoxamine Jazz Pharmaceuticals,
maleate) Extended- Inc., 3180 Porter
Release Capsules, 100 Dr., Palo Alto, CA
mg and 150 mg. 94304.
NDA 022106............. Doribax (doripenem) for Shionogi, Inc., 300
Injection, 250 mg/vial Campus Dr., Florham
and 500 mg/vial. Park, NJ 07932.
NDA 022386............. PrandiMet (metformin Novo Nordisk, Inc.,
HCl; repaglinide) P.O. Box 846,
Tablets, 500mg; 1 mg Plainsboro, NJ 08536.
and 500 mg; 2 mg.
NDA 050201............. Ophthocort Parkedale
(chloramphenicol, Pharmaceuticals,
hydrocortisone Subsidiary of Pfizer
acetate, polymyxin B Inc., 235 East 42nd
sulfate) Ophthalmic St., New York, NY
Ointment USP, 10 mg/g; 10017.
5 mg/g; 10,000 units/g.
NDA 050344............. Statrol (neomycin Alcon Laboratories,
sulfate; polymyxin B Inc., 6201 South
sulfate) Ophthalmic Freeway, TC-45, Fort
Ointment, EQ 3.5 mg Worth, TX 76134.
base/g; 10,000 units/g.
NDA 050442............. Vibramycin (doxycycline Pfizer, Inc., 235 East
hyclate) Injection, EQ 42nd St., New York,
to 200 mg base/vial NY 10017.
and EQ 100 mg base/
vial.
NDA 050497............. Ticar (ticarcillin GlaxoSmithKline, 1250
disodium) Injection, Collegeville Rd.,
EQ 1 g base/vial, EQ 3 Collegeville, PA
g base/vial, EQ 6 g 19426.
base/vial, EQ 20 g
base/vial, and EQ 30 g
base/vial.
NDA 050512............. Duricef (cefadroxil Warner Chilcott Co.,
monohydrate) USP LLC, 100 Enterprise
Capsules, EQ 500 mg Dr., Rockaway, NJ
base and EQ 250 mg 07866.
base.
NDA 050527............. Duricef (cefadroxil Do.
monohydrate) USP For
Oral Suspension, EQ
125 mg base/5 mL, EQ
250 mg base/5 mL, and
EQ 500 mg base/5 mL.
NDA 050593............. Eryc Sprinkles Hospira Inc., 275
(erythromycin) North Field Dr., Lake
Capsules, 125 mg. Forest, IL 60045.
NDA 050646............. Ceptaz (ceftazidime) GlaxoSmithKline.
Injection, 500 mg/
vial, 1 g/vial, 2 g/
vial, and 10 g/vial.
NDA 050668............. Lorabid (loracarbef) King Pharmaceuticals,
Capsules USP, 200 mg Inc., 501 Fifth St.,
and 400 mg. Bristol, TN 37620.
NDA 050792............. Cefotaxime and Dextrose B. Braun Medical, Inc.
2.4% in Plastic
Container, EQ 2 g
base, and Cefotaxime
and Dextrose 3.9% in
Plastic Container, EQ
1 g base.
[[Page 32306]]
NDA 050807............. Epirubicin HCl for Hospira, Inc.
Injection, 50 mg/vial,
200 mg/vial.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
August 13, 2018. 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 August 13, 2018 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: July 9, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-14935 Filed 7-11-18; 8:45 am]
BILLING CODE 4164-01-P