[Federal Register Volume 78, Number 139 (Friday, July 19, 2013)]
[Notices]
[Pages 43210-43214]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17324]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0845]
Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug
Applications and 77 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of 52 new drug applications (NDAs) and 77 abbreviated new drug
applications (ANDAs) 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be withdrawn.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: Effective August 19, 2013.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: The holders of the applications listed in
[[Page 43211]]
table 1 in this document 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.
Table 1
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 011620................. Cardiografin Bracco Diagnostics,
(diatrizoate 107 College Rd.
meglumine USP, 85%) East, Princeton, NJ
Injection. 08540.
NDA 012828................. Travase (sutilains) Abbott Laboratories,
Ointment. PA 77/Bldg. AP30-
1E, 200 Abbott Park
Rd., Abbott Park,
IL 60064-6157.
NDA 014215................. Celestone Merck Sharp & Dohme
(betamethasone) Oral Corp., One Merck
Solution. Dr., P.O. Box 100,
Whitehouse Station,
NJ 08889.
NDA 014685................. Aventyl Ranbaxy Inc., U.S.
(nortriptyline Agent for Ranbaxy
hydrochloride (HCl) Laboratories
Oral Solution, 10 Limited, 600
milligrams (mg)/5 College Rd. East,
milliliters (mL). Princeton, NJ
08540.
NDA 014860................. Aralen Phosphate Sanofi-Aventis U.S.,
(chloroquine LLC, 55 Corporate
phosphate) with Dr., Bridgewater,
primaquine phosphate NJ 08807-0890.
Tablets.
NDA 016017................. Cloroquine-Primaquine Do.
(chloroquine
phosphate and
primaquine
phosphate) Tablets.
NDA 016019................. Questran Resin Bristol-Myers Squibb
(cholestyramine Co., P.O. Box 4000,
resin). Princeton, NJ 08543-
4000.
NDA 016640................. Questran Powder Do.
(cholestyramine for
oral suspension).
NDA 016721................. Dalmane (flurazepam Valeant
HCl) Capsules. Pharmaceuticals
North America, LLC,
700 Route 202/206
North, Bridgewater,
NJ 08807.
NDA 016732................. Talwin 50 Sanofi-Aventis U.S.,
(pentazocine HCl LLC.
USP), Tablets, 50 mg.
NDA 016891................. Talwin Compound Do.
(pentazocine HCl USP
and aspirin USP),
Equivalent to (EQ)
12.5 mg (base) and
325 mg.
NDA 016927................. Demulen 1/50-21 G.D. Searle, LLC, c/
(ethynodiol o Pfizer Inc., 235
diacetate/ethinyl East 42nd St., New
estradiol) Tablets. York, NY 10017.
NDA 016936................. Demulen 1/50-28 Do.
(ethynodiol
diacetate/ethinyl
estradiol) Tablets.
NDA 017557................. Danocrine (danazol) Sanofi-Aventis U.S.,
Capsules. LLC.
NDA 017633................. Glycine Irrigation Hospira, Inc., 275
USP, 1.5%. North Field Dr.,
Lake Forest, IL
60045.
NDA 017821................. Flexeril Janssen Research &
(cyclobenzaprine Development, LLC,
HCl) Tablets, 5 mg 1125 Trenton-
and 10 mg. Harbourton Rd.,
Titusville, NJ
08560.
NDA 017850................. Klotrix (potassium Bristol-Myers Squibb
chloride) Extended- Co.
Release Tablets.
NDA 017857................. Stadol (butorphanol Do.
tartrate USP)
Injection.
NDA 018160................. Demulen 1/35-28 G.D. Searle, LLC, c/
(ethynodiol o Pfizer Inc.
diacetate/ethinyl
estradiol) Tablets.
NDA 018168................. Demulen 1/35-21 Do.
(ethynodiol
diacetate/ethinyl
estradiol) Tablets.
ANDA 018398................ Dopamine HCl Baxter Healthcare
Injection USP, 40 mg/ Corp., 25212 W.
mL and 80 mg/mL. Illinois Route 120,
Round Lake, IL
60073.
NDA 018458................. Talacen (pentazocine Sanofi-Aventis U.S.,
HCl USP and LLC.
acetaminophen USP),
Tablets, EQ 25 mg
(base) and 650 mg.
ANDA 018581................ Sodium Nitroprusside Baxter Healthcare
for Injection USP, Corp.
50 mg/vial.
NDA 018733................. Talwin Nx Sanofi-Aventis U.S.,
(pentazocine HCl and LLC.
naloxone HCl)
Tablets, 50 mg and
0.5 mg.
NDA 018981................. Enkaid (encainide Bristol-Myers Squibb
HCl) Capsules. Co.
NDA 019057................. Hytrin (terazosin Abbott Laboratories.
HCl) Tablets, 1 mg,
2 mg, 5 mg, and 10
mg.
NDA 019436................. Primacor (milrinone Sanofi-Aventis U.S.,
lactate) Injection, LLC.
EQ 1 mg (base)/mL.
NDA 019507................. Kerlone (betaxolol Do.
HCl) Tablets, 10 mg
and 20 mg.
NDA 019578................. Mefloquine HCl U.S. Army Office of
Tablets, 250 mg. the Surgeon
General, Department
of the Army, 1430
Veterans Dr., Fort
Detrick, MD 21702-
5009.
NDA 019669................. Questran Light, Bristol-Myers Squibb
Questran II, and Co.
Questran Sugar Free
(cholestyramine for
oral suspension).
NDA 019807................. Kerledex (betaxolol Sanofi-Aventis U.S.,
HCl and LLC.
chlorthalidone)
Tablets.
NDA 019977................. Oramorph SR (morphine Xanodyne
sulfate) Sustained- Pharmaceuticals,
Release Tablets, 15 Inc., One
mg, 30 mg, 60 mg, Riverfront Pl.,
and 100 mg. Newport, KY 41071.
NDA 020036................. Aredia (pamidronate Novartis
disodium) for Pharmacueticals
injection, 30 mg, 60 Corp., One Health
mg, and 90 mg. Plaza, East
Hanover, NJ 07936-
1080.
NDA 020038................. Fludara (fludarabine Genzyme Corp., 500
phosphate) for Kendall St.,
Injection, 50 mg/ Cambridge, MA
vial. 02142.
NDA 020056................. Atropine Sulfate U.S. Army Office of
Aerosol for the Surgeon
Inhalation. General.
NDA 020070................. Cognex (tacrine HCl) Shionogi Inc., 300
Capsules, 10 mg, 20 Campus Dr., Florham
mg, 30 mg, and 40 mg. Park, NJ 07932.
NDA 020095................. Zantac (ranitidine GlaxoSmithKline,
HCl) Geldose P.O. Box 13398, 5
Capsules. Moore Dr., Research
Triangle Park, NC
27709.
NDA 020151................. Effexor (venlafaxine Wyeth
HCl) Tablets, 12.5 Pharmaceuticals,
mg, 25 mg, 37.5 mg, Inc., 235 East 42nd
50 mg, 75 mg, and St., New York, NY
100 mg. 10017.
NDA 020239................. Kytril (granisetron Hoffman-La Roche,
HCl) Injection, EQ 1 Inc., c/o
mg (base)/mL and 0.1 Genentech, Inc., 1
mg (base)/mL, 1 mg DNA Way, South San
(base)/mL, and 3 mg Francisco, CA
(base)/mL. 94080.
[[Page 43212]]
NDA 020305................. Kytril (granisetron Do.
HCl) Tablets, EQ 1
mg (base), EQ 2 mg
(base).
NDA 020336................. DynaCirc CR GlaxoSmithKline,
(isradipine) 2301 Renaissance
Controlled-Release Blvd., King of
Tablets. Prussia, PA 19406.
NDA 020343................. Primacor (milrinone Sanofi-Aventis U.S.,
lactate) Injection. LLC.
NDA 020347................. Hytrin (terazosin Abbott Laboratories.
HCl) Capsules, 1 mg,
2 mg, 5, mg, and 10
mg.
NDA 020441................. Pulmicort Turbuhaler AstraZeneca, 1800
(budesonide) Concord Pike, P.O.
Inhalation Powder. Box 8355,
Wilmington, DE
19803-8355.
NDA 020484................. Innohep (tinzaparin LEO Pharma A/S, c/o
sodium) Injection. Parexel
International
Corp., 4600 East-
West Highway, Suite
350, Bethesda, MD
20814.
NDA 020611................. Dovonex LEO Pharma A/S, c/o
(calcipotriene) LEO Pharma Inc., 1
Topical Solution, Sylvan Way,
0.005%. Parsippany, NJ
07054.
NDA 020680................. Norvir (ritonavir) Abbott Laboratories.
Capsules, 100 mg.
NDA 021238................. Kytril (granisetron Hoffman-La Roche,
HCl) Oral Solution, Inc., c/o
2 mg/10 mL. Genentech, Inc.
NDA 021320................. Plenaxis (abarelix) Specialty European
Injection, 100 mg/ Pharma Limited, c/o
vial. Strategic
Bioscience Corp.,
93 Birch Hill Rd.,
Stow, MA 01775.
NDA 021744................. Proquin XR Depomed Inc., 1360
(ciprofloxacin HCl) O'Brien Dr., Menlo
Tablets, 500 mg. Park, CA 94025.
NDA 022021................. Altace (ramipril) King Pharmaceuticals
Tablets, 1.25 mg, Inc., c/o Pfizer
2.5 mg, 5 mg, and 10 Inc., 235 East 42nd
mg. St., New York, NY
10017.
NDA 022026................. Amlodipine Besylate Synthon
Orally Pharmaceuticals,
Disintegrating Inc., 9000
Tablets, 2.5 mg, 5 Development Dr.,
mg, and 10 mg. P.O. Box 110487,
Research Triangle
Park, NC 27709.
NDA 022456................. Omeprazole, Sodium Santarus, Inc., 3721
Bicarbonate, and Valley Centre Dr.,
Magnesium Hydroxide Suite 400, San
Tablets. Diego, CA 92130.
ANDA 040015................ Neosar Teva Parenteral
(cyclophosphamide) Medicines, Inc., 19
for Injection, 100 Hughes, Irvine, CA
mg, 200 mg, 500 mg, 92618.
1 gram (gm), and 2
gm vials.
ANDA 040079................ Thiamine HCl Hospira, Inc.
Injection USP, 100
mg/mL.
ANDA 040131................ Edrophonium Chloride Do.
Injection, 10 mg/mL.
ANDA 040162................ Prochlorperazine IVAX
Maleate Tablets USP, Pharmaceuticals,
5 mg and 10 mg. Inc., Subsidiary of
Teva
Pharmaceuticals
USA, 400 Chestnut
Ridge Rd.,
Woodcliff Lake, NJ
07677.
ANDA 040272................ Oxycodone and Duramed
Acetaminophen Pharmaceuticals,
Tablets USP, 5 mg/ Inc., Subsidiary of
325 mg. Barr Laboratories,
Inc., Indirect
Wholly Owned
Subsidiary of Teva
Pharmaceuticals
USA, 400 Chestnut
Ridge Rd.,
Woodcliff Lake, NJ
07677.
ANDA 040332................ Leucovorin Calcium Teva Parenteral
Injection USP, 10 mg Medicines, Inc.
(base).
ANDA 040364................ Prednisolone Syrup, Nesher
15 mg/5 mL. Pharmaceuticals
(USA) LLC, 13910
Saint Charles Rock
Rd., Bridgton, MO
63044.
ANDA 040373................ Hydralazine HCl Teva Parenteral
Injection USP, 20 mg/ Medicines, Inc.
mL.
ANDA 040423................ Prednisolone Syrup, 5 Nesher
mg/5 mL. Pharmaceuticals
(USA) LLC.
ANDA 040505................ Prochlorperazine Teva Parenteral
Edisylate Injection Medicines, Inc.
USP, 5 mg/mL.
ANDA 040641................ Methylprednisolone Bedford
Sodium Succinate for Laboratories, 300
Injection USP, 125 Northfield Rd.,
mg/vial, 500 mg/ Bedford, OH 44146.
vial, and 1 gm/vial.
ANDA 040662................ Methylprednisolone Do.
Sodium Succinate for
Injection USP, 40 mg/
vial.
ANDA 040709................ Methylprednisolone Do.
Sodium Succinate for
Injection USP, 500
mg/vial and 1 gm/
vial.
ANDA 040795................ Benzonatate Capsules Nesher
USP, 100 mg and 200 Pharmaceuticals
mg. (USA) LLC.
ANDA 040909................ Sodium Polystyrene Citrus Pharma, LLC,
Sulfonate Powder for 3940 Quebec Ave.
Suspension, 454 gm/ North, Minneapolis,
bottle. MN 55427.
NDA 050261................. Declomycin CorePharma, LLC, 215
(demeclocycline HCl) Wood Ave.,
Tablets, 75 mg, 150 Middllesex, NJ
mg, and 300 mg. 08846-2554.
ANDA 060003................ V-Cillin K (pencillin Eli Lilly and Co.,
V potassium tablets Lilly Corporate
USP), 125 mg, 250 Center,
mg, and 500 mg. Indianapolis, IN
46285.
ANDA 060517................ Fugizone Bristol-Myers Squibb
(amphotericin B) for Co.
Injection.
ANDA 060575................ Mycostatin (nystatin) Do.
Cream, 100,000 units/
gm.
ANDA 061901................ Kantrex (kanamycin Sandoz Inc., 2555 W.
sulfate injection Midway Blvd.,
USP) Injection,75 mg/ Broomfield, CO
2 mL, 500 mg/2 mL, 80038-0446.
and 1 gm/3 mL.
ANDA 062008................ Nebcin (tobramycin Eli Lilly and Co.
for injection USP).
ANDA 062311................ Amikin (amikacin Brisol-Myers Squibb
sulfate injection Co.
USP), 50 mg/mL and
250 mg/mL.
ANDA 062707................ Nebcin (tobramycin Eli Lilly and Co.
for injection USP).
ANDA 063041................ Clindamycin Injection Teva Parenteral
USP. Medicines, Inc.
ANDA 063080................ Tobramycin Injection Hospira, Inc.
USP.
ANDA 063149................ Gentamicin Injection Teva Parenteral
USP, 10 mg/mL. Medicines, Inc.
ANDA 063282................ Clindamycin Phosphate Do.
Injection, EQ 150 mg
(base)/mL.
ANDA 063253................ Erythromycin Do.
Lactobionate for
Injection USP, 500
mg (base)/vial and 1
gm (base)/vial.
ANDA 064021................ Tobramycin Sulfate Bristol-Myers Squibb
Injection. Co.
Amphotericin B for Teva Parenteral
Injection USP, 50 mg/ Medicines, Inc.
vial.
ANDA 064212................ Daunorubicin HCl for Do.
Injection USP, 20 mg
(base)/vial and 50
mg (base)/vial.
[[Page 43213]]
ANDA 065037................ Idarubicin HCl for Do.
Injection USP, 5 mg/
vial, 10 mg/vial,
and 20 mg/vial.
ANDA 065321................ Nystatin Topical Nesher
Powder USP, 100,000 Pharmaceuticals
units/gm. (USA) LLC.
ANDA 065433................ Mycophenolate Mofetil Zydus
Capsules, 250 mg. Pharmaceuticals
(USA) Inc., 73
Route 31 North,
Pennington, NJ
08534.
ANDA 065477................ Mycophenolate Mofetil Do.
Tablets, 500 mg.
ANDA 070159................ Tolazamide Tablets Par Pharmaceutical,
USP, 100 mg. Inc., One Ram Ridge
Rd., Spring Valley,
NY 10977.
ANDA 070160................ Tolazamide Tablets Do.
USP, 250 mg.
ANDA 070161................ Tolazamide Tablets Do.
USP, 500 mg.
ANDA 070431................ Valproic Acid Do.
Capsules, 250 mg.
ANDA 070577................ Verapamil HCl Hospira, Inc.
Injection USP, 2.5
mg/mL.
ANDA 070818................ Ibuprofen Tablets Ohm Laboratories, c/
USP, 400 mg. o Ranbaxy Inc., 600
College Rd. East,
Princeton, NJ
08540.
ANDA 070980................ Potassium Chloride Nesher
Extended-Release Pharmaceuticals
Capsules USP, 10 (USA) LLC.
milliequivalents.
ANDA 071200................ Disopyramide Do.
Phosphate Extended-
Release Capsules
USP, 150 mg.
ANDA 071726................ Metaproterenol Nephron
Sulfate Inhalation Pharmaceuticals
Solution, 0.6%. Corp., 4121 South
West 34th St.,
Orlando, FL 32811.
ANDA 071855................ Metaproterenol Do.
Sulfate Inhalation
Solution, 0.4%.
ANDA 072273................ Albuterol Inhalation Armstrong
Aerosol\1\. Pharmaceuticals,
Inc. 25 John Rd.,
Canton, MA 02021.
ANDA 072437................ Fenoprofen Calcium Par Pharmaceuticals,
Capsules USP, 200 mg. Inc.
ANDA 072974................ Methyldopate HCl Teva Parenteral
Injection USP. Medicines, Inc.
ANDA 073000................ Dopamine HCl Do.
Injection USP, 80 mg/
mL.
ANDA 073117................ Metoclopramine Hospira, Inc.
Injection USP, 5 mg/
mL.
ANDA 073465................ Sodium Nitroprusside Teva Parenteral
Injection, 25 mg/mL. Medicines, Inc.
ANDA 073617................ Pentamidine Baxter Healthcare
Isethionate for Corp.
Injection, 300 mg/
vial.
ANDA 073683................ Cyclobenzaprine HCl Sandoz Inc.
Tablets, 10 mg.
ANDA 074013................ Pindolol Tablets USP, Mylan
5 mg. Pharmaceuticals,
Inc., 781 Chestnut
Ridge Rd., P.O. Box
4310, Morgantown,
WV 26505-4310.
ANDA 074018................ Pindolol Tablets USP, Do.
10 mg.
ANDA 074105................ Naproxen Tablets USP, DAVA
250 mg, 375 mg, and Pharmaceuticals,
500 mg. Inc., Parker Plaza,
400 Kelby St., 10th
Floor, Fort Lee, NJ
07024.
ANDA 074147................ Metoclopramide Hospira, Inc.
Injection USP, 5 mg/
mL.
ANDA 074206................ Dobutamine Injection Teva Parenteral
USP, 250 mg (base)/ Medicines, Inc.
20 mL.
ANDA 074252................ Cimetidine HCl Do.
Injection, EQ 300 mg
(base)/2 mL.
ANDA 074519................ Captopril Tablets, Sandoz Inc.
12.5 mg, 25 mg, 50
mg, and 100 mg.
ANDA 074613................ Bumetanide Injection Teva Parenteral
USP, 0.25 mg/mL. Medicines, Inc.
ANDA 074616................ Inamrinone Lactate Hospira, Inc.
Injection, 5 mg/mL.
ANDA 074629................ Iopamidol Injection Baxter Healthcare
USP, 41%, 51%, 61%, Corp.
and 76%.
ANDA 074637................ Iopamidol Injection Hospira, Inc.
USP, 61%.
ANDA 074753................ Atracurium Besylate Baxter Healthcare
Injection USP, 10 mg/ Corp.
mL (preserved).
ANDA 074768................ Atracurium Besylate Do.
Injection USP, 10 mg/
mL (preservative
free).
ANDA 074784................ Atracurium Besylate Teva Parenteral
Injection USP, 10 mg/ Medicines, Inc.
mL.
ANDA 074795................ Fluphenazine Do.
Decanoate Injection
USP, 25 mg/mL.
ANDA 074969................ Acyclovir for Do.
Injection USP, 500
mg/vial and 1,000 mg/
vial.
ANDA 075004................ Diltiazem HCl Hospira, Inc.
Injection, 5 mg/mL.
ANDA 075005................ Iopamidol Injection Do.
USP, 51%, 61%, and
76%.
ANDA 075012................ Etodolac Tablets USP, Mylan
400 mg and 500 mg. Pharmaceuticals,
Inc.
ANDA 075071................ Etodolac Capsules, Do.
200 mg and 300 mg.
ANDA 075119................ Buspirone HCl Tablet Egis Pharmaceuticals
USP, 5 mg, 10 mg, PLC, c/o GlobePharm
and 15 mg. Inc., 313 Pine St.,
Suite 204,
Deerfield, IL
60015.
NDA 075166................. Isosorbide SkyePharma AG, c/o
Mononitrate Extended- Compliance
Release Tablets, 60 Resources, LLC,
mg. 7100 Farmington
Lane, Hillsborough,
NC 27278.
ANDA 075328................ Pemoline Tablets, Vintage
18.75 mg, 37.5 mg, Pharmaceuticals,
and 75 mg. 120 Vintage Dr.,
Huntsville, AL
35811.
ANDA 075392................ Propofol Injectable Teva Parenteral
Emulsion, 10 mg/mL. Medicines, Inc.
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\1\ This product included an oral pressurized metered-dose inhaler that
contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no
longer be used as a propellant for any albuterol metered-dose inhalers
(see 70 FR 17168, April 4, 2005).
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and under authority
delegated to the Director, Center for Drug Evaluation and Research, by
the Commissioner, approval of the applications listed in table 1 in
this document, and all amendments and supplements thereto, is hereby
withdrawn, effective August 19, 2013. Introduction or delivery for
introduction into interstate commerce of products without approved new
drug applications violates section 301(a) and (d) of the FD&C Act (21
U.S.C. 331(a) and (d)). Drug products that are listed in table 1 that
are in inventory on the date that this notice becomes effective (see
[[Page 43214]]
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: July 15, 2013.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
[FR Doc. 2013-17324 Filed 7-18-13; 8:45 am]
BILLING CODE 4160-01-P