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78 FR 139 pgs. 43210-43214 - Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications

Type: NOTICEVolume: 78Number: 139Pages: 43210 - 43214
Docket number: [Docket No. FDA-2013-N-0845]
FR document: [FR Doc. 2013-17324 Filed 7-18-13; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version:  PDF Version
Pages: 43210, 43211, 43212, 43214

[top] page 43210

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.

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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:


[top] 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 § 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.

page 43212page 43213


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Application No. Drug Applicant
NDA 011620 Cardiografin (diatrizoate meglumine USP, 85%) Injection Bracco Diagnostics, 107 College Rd. East, Princeton, NJ 08540.
NDA 012828 Travase (sutilains) Ointment Abbott Laboratories, PA 77/Bldg. AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157.
NDA 014215 Celestone (betamethasone) Oral Solution Merck Sharp & Dohme Corp., One Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889.
NDA 014685 Aventyl (nortriptyline hydrochloride (HCl) Oral Solution, 10 milligrams (mg)/5 milliliters (mL) Ranbaxy Inc., U.S. Agent for Ranbaxy Laboratories Limited, 600 College Rd. East, Princeton, NJ 08540.
NDA 014860 Aralen Phosphate (chloroquine phosphate) with primaquine phosphate Tablets Sanofi-Aventis U.S., LLC, 55 Corporate Dr., Bridgewater, NJ 08807-0890.
NDA 016017 Cloroquine-Primaquine (chloroquine phosphate and primaquine phosphate) Tablets Do.
NDA 016019 Questran Resin (cholestyramine resin) Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000.
NDA 016640 Questran Powder (cholestyramine for oral suspension) Do.
NDA 016721 Dalmane (flurazepam HCl) Capsules Valeant Pharmaceuticals North America, LLC, 700 Route 202/206 North, Bridgewater, NJ 08807.
NDA 016732 Talwin 50 (pentazocine HCl USP), Tablets, 50 mg Sanofi-Aventis U.S., LLC.
NDA 016891 Talwin Compound (pentazocine HCl USP and aspirin USP), Equivalent to (EQ) 12.5 mg (base) and 325 mg Do.
NDA 016927 Demulen 1/50-21 (ethynodiol diacetate/ethinyl estradiol) Tablets G.D. Searle, LLC, c/o Pfizer Inc., 235 East 42nd St., New York, NY 10017.
NDA 016936 Demulen 1/50-28 (ethynodiol diacetate/ethinyl estradiol) Tablets Do.
NDA 017557 Danocrine (danazol) Capsules Sanofi-Aventis U.S., LLC.
NDA 017633 Glycine Irrigation USP, 1.5% Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045.
NDA 017821 Flexeril (cyclobenzaprine HCl) Tablets, 5 mg and 10 mg Janssen Research & Development, LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ 08560.
NDA 017850 Klotrix (potassium chloride) Extended-Release Tablets Bristol-Myers Squibb Co.
NDA 017857 Stadol (butorphanol tartrate USP) Injection Do.
NDA 018160 Demulen 1/35-28 (ethynodiol diacetate/ethinyl estradiol) Tablets G.D. Searle, LLC, c/o Pfizer Inc.
NDA 018168 Demulen 1/35-21 (ethynodiol diacetate/ethinyl estradiol) Tablets Do.
ANDA 018398 Dopamine HCl Injection USP, 40 mg/mL and 80 mg/mL Baxter Healthcare Corp., 25212 W. Illinois Route 120, Round Lake, IL 60073.
NDA 018458 Talacen (pentazocine HCl USP and acetaminophen USP), Tablets, EQ 25 mg (base) and 650 mg Sanofi-Aventis U.S., LLC.
ANDA 018581 Sodium Nitroprusside for Injection USP, 50 mg/vial Baxter Healthcare Corp.
NDA 018733 Talwin Nx (pentazocine HCl and naloxone HCl) Tablets, 50 mg and 0.5 mg Sanofi-Aventis U.S., LLC.
NDA 018981 Enkaid (encainide HCl) Capsules Bristol-Myers Squibb Co.
NDA 019057 Hytrin (terazosin HCl) Tablets, 1 mg, 2 mg, 5 mg, and 10 mg Abbott Laboratories.
NDA 019436 Primacor (milrinone lactate) Injection, EQ 1 mg (base)/mL Sanofi-Aventis U.S., LLC.
NDA 019507 Kerlone (betaxolol HCl) Tablets, 10 mg and 20 mg Do.
NDA 019578 Mefloquine HCl Tablets, 250 mg U.S. Army Office of the Surgeon General, Department of the Army, 1430 Veterans Dr., Fort Detrick, MD 21702-5009.
NDA 019669 Questran Light, Questran II, and Questran Sugar Free (cholestyramine for oral suspension) Bristol-Myers Squibb Co.
NDA 019807 Kerledex (betaxolol HCl and chlorthalidone) Tablets Sanofi-Aventis U.S., LLC.
NDA 019977 Oramorph SR (morphine sulfate) Sustained-Release Tablets, 15 mg, 30 mg, 60 mg, and 100 mg Xanodyne Pharmaceuticals, Inc., One Riverfront Pl., Newport, KY 41071.
NDA 020036 Aredia (pamidronate disodium) for injection, 30 mg, 60 mg, and 90 mg Novartis Pharmacueticals Corp., One Health Plaza, East Hanover, NJ 07936-1080.
NDA 020038 Fludara (fludarabine phosphate) for Injection, 50 mg/vial Genzyme Corp., 500 Kendall St., Cambridge, MA 02142.
NDA 020056 Atropine Sulfate Aerosol for Inhalation U.S. Army Office of the Surgeon General.
NDA 020070 Cognex (tacrine HCl) Capsules, 10 mg, 20 mg, 30 mg, and 40 mg Shionogi Inc., 300 Campus Dr., Florham Park, NJ 07932.
NDA 020095 Zantac (ranitidine HCl) Geldose Capsules GlaxoSmithKline, P.O. Box 13398, 5 Moore Dr., Research Triangle Park, NC 27709.
NDA 020151 Effexor (venlafaxine HCl) Tablets, 12.5 mg, 25 mg, 37.5 mg, 50 mg, 75 mg, and 100 mg Wyeth Pharmaceuticals, Inc., 235 East 42nd St., New York, NY 10017.
NDA 020239 Kytril (granisetron HCl) Injection, EQ 1 mg (base)/mL and 0.1 mg (base)/mL, 1 mg (base)/mL, and 3 mg (base)/mL Hoffman-La Roche, Inc., c/o Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080.
NDA 020305 Kytril (granisetron HCl) Tablets, EQ 1 mg (base), EQ 2 mg (base) Do.
NDA 020336 DynaCirc CR (isradipine) Controlled-Release Tablets GlaxoSmithKline, 2301 Renaissance Blvd., King of Prussia, PA 19406.
NDA 020343 Primacor (milrinone lactate) Injection Sanofi-Aventis U.S., LLC.
NDA 020347 Hytrin (terazosin HCl) Capsules, 1 mg, 2 mg, 5, mg, and 10 mg Abbott Laboratories.
NDA 020441 Pulmicort Turbuhaler (budesonide) Inhalation Powder AstraZeneca, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355.
NDA 020484 Innohep (tinzaparin sodium) Injection LEO Pharma A/S, c/o Parexel International Corp., 4600 East-West Highway, Suite 350, Bethesda, MD 20814.
NDA 020611 Dovonex (calcipotriene) Topical Solution, 0.005% LEO Pharma A/S, c/o LEO Pharma Inc., 1 Sylvan Way, Parsippany, NJ 07054.
NDA 020680 Norvir (ritonavir) Capsules, 100 mg Abbott Laboratories.
NDA 021238 Kytril (granisetron HCl) Oral Solution, 2 mg/10 mL Hoffman-La Roche, Inc., c/o Genentech, Inc.
NDA 021320 Plenaxis (abarelix) Injection, 100 mg/vial Specialty European Pharma Limited, c/o Strategic Bioscience Corp., 93 Birch Hill Rd., Stow, MA 01775.
NDA 021744 Proquin XR (ciprofloxacin HCl) Tablets, 500 mg Depomed Inc., 1360 O'Brien Dr., Menlo Park, CA 94025.
NDA 022021 Altace (ramipril) Tablets, 1.25 mg, 2.5 mg, 5 mg, and 10 mg King Pharmaceuticals Inc., c/o Pfizer Inc., 235 East 42nd St., New York, NY 10017.
NDA 022026 Amlodipine Besylate Orally Disintegrating Tablets, 2.5 mg, 5 mg, and 10 mg Synthon Pharmaceuticals, Inc., 9000 Development Dr., P.O. Box 110487, Research Triangle Park, NC 27709.
NDA 022456 Omeprazole, Sodium Bicarbonate, and Magnesium Hydroxide Tablets Santarus, Inc., 3721 Valley Centre Dr., Suite 400, San Diego, CA 92130.
ANDA 040015 Neosar (cyclophosphamide) for Injection, 100 mg, 200 mg, 500 mg, 1 gram (gm), and 2 gm vials Teva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618.
ANDA 040079 Thiamine HCl Injection USP, 100 mg/mL Hospira, Inc.
ANDA 040131 Edrophonium Chloride Injection, 10 mg/mL Do.
ANDA 040162 Prochlorperazine Maleate Tablets USP, 5 mg and 10 mg IVAX Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 040272 Oxycodone and Acetaminophen Tablets USP, 5 mg/325 mg Duramed Pharmaceuticals, Inc., Subsidiary of Barr Laboratories, Inc., Indirect Wholly Owned Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 040332 Leucovorin Calcium Injection USP, 10 mg (base) Teva Parenteral Medicines, Inc.
ANDA 040364 Prednisolone Syrup, 15 mg/5 mL Nesher Pharmaceuticals (USA) LLC, 13910 Saint Charles Rock Rd., Bridgton, MO 63044.
ANDA 040373 Hydralazine HCl Injection USP, 20 mg/mL Teva Parenteral Medicines, Inc.
ANDA 040423 Prednisolone Syrup, 5 mg/5 mL Nesher Pharmaceuticals (USA) LLC.
ANDA 040505 Prochlorperazine Edisylate Injection USP, 5 mg/mL Teva Parenteral Medicines, Inc.
ANDA 040641 Methylprednisolone Sodium Succinate for Injection USP, 125 mg/vial, 500 mg/vial, and 1 gm/vial Bedford Laboratories, 300 Northfield Rd., Bedford, OH 44146.
ANDA 040662 Methylprednisolone Sodium Succinate for Injection USP, 40 mg/vial Do.
ANDA 040709 Methylprednisolone Sodium Succinate for Injection USP, 500 mg/vial and 1 gm/vial Do.
ANDA 040795 Benzonatate Capsules USP, 100 mg and 200 mg Nesher Pharmaceuticals (USA) LLC.
ANDA 040909 Sodium Polystyrene Sulfonate Powder for Suspension, 454 gm/bottle Citrus Pharma, LLC, 3940 Quebec Ave. North, Minneapolis, MN 55427.
NDA 050261 Declomycin (demeclocycline HCl) Tablets, 75 mg, 150 mg, and 300 mg CorePharma, LLC, 215 Wood Ave., Middllesex, NJ 08846-2554.
ANDA 060003 V-Cillin K (pencillin V potassium tablets USP), 125 mg, 250 mg, and 500 mg Eli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285.
ANDA 060517 Fugizone (amphotericin B) for Injection Bristol-Myers Squibb Co.
ANDA 060575 Mycostatin (nystatin) Cream, 100,000 units/gm Do.
ANDA 061901 Kantrex (kanamycin sulfate injection USP) Injection,75 mg/2 mL, 500 mg/2 mL, and 1 gm/3 mL Sandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80038-0446.
ANDA 062008 Nebcin (tobramycin for injection USP) Eli Lilly and Co.
ANDA 062311 Amikin (amikacin sulfate injection USP), 50 mg/mL and 250 mg/mL Brisol-Myers Squibb Co.
ANDA 062707 Nebcin (tobramycin for injection USP) Eli Lilly and Co.
ANDA 063041 Clindamycin Injection USP Teva Parenteral Medicines, Inc.
ANDA 063080 Tobramycin Injection USP Hospira, Inc.
ANDA 063149 Gentamicin Injection USP, 10 mg/mL Teva Parenteral Medicines, Inc.
ANDA 063282 Clindamycin Phosphate Injection, EQ 150 mg (base)/mL Do.
ANDA 063253 Erythromycin Lactobionate for Injection USP, 500 mg (base)/vial and 1 gm (base)/vial Do.
ANDA 064021 Tobramycin Sulfate Injection Bristol-Myers Squibb Co.
Amphotericin B for Injection USP, 50 mg/vial Teva Parenteral Medicines, Inc.
ANDA 064212 Daunorubicin HCl for Injection USP, 20 mg (base)/vial and 50 mg (base)/vial Do.
ANDA 065037 Idarubicin HCl for Injection USP, 5 mg/vial, 10 mg/vial, and 20 mg/vial Do.
ANDA 065321 Nystatin Topical Powder USP, 100,000 units/gm Nesher Pharmaceuticals (USA) LLC.
ANDA 065433 Mycophenolate Mofetil Capsules, 250 mg Zydus Pharmaceuticals (USA) Inc., 73 Route 31 North, Pennington, NJ 08534.
ANDA 065477 Mycophenolate Mofetil Tablets, 500 mg Do.
ANDA 070159 Tolazamide Tablets USP, 100 mg Par Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977.
ANDA 070160 Tolazamide Tablets USP, 250 mg Do.
ANDA 070161 Tolazamide Tablets USP, 500 mg Do.
ANDA 070431 Valproic Acid Capsules, 250 mg Do.
ANDA 070577 Verapamil HCl Injection USP, 2.5 mg/mL Hospira, Inc.
ANDA 070818 Ibuprofen Tablets USP, 400 mg Ohm Laboratories, c/o Ranbaxy Inc., 600 College Rd. East, Princeton, NJ 08540.
ANDA 070980 Potassium Chloride Extended-Release Capsules USP, 10 milliequivalents Nesher Pharmaceuticals (USA) LLC.
ANDA 071200 Disopyramide Phosphate Extended-Release Capsules USP, 150 mg Do.
ANDA 071726 Metaproterenol Sulfate Inhalation Solution, 0.6% Nephron Pharmaceuticals Corp., 4121 South West 34th St., Orlando, FL 32811.
ANDA 071855 Metaproterenol Sulfate Inhalation Solution, 0.4% Do.
ANDA 072273 Albuterol Inhalation Aerosol1 Armstrong Pharmaceuticals, Inc. 25 John Rd., Canton, MA 02021.
ANDA 072437 Fenoprofen Calcium Capsules USP, 200 mg Par Pharmaceuticals, Inc.
ANDA 072974 Methyldopate HCl Injection USP Teva Parenteral Medicines, Inc.
ANDA 073000 Dopamine HCl Injection USP, 80 mg/mL Do.
ANDA 073117 Metoclopramine Injection USP, 5 mg/mL Hospira, Inc.
ANDA 073465 Sodium Nitroprusside Injection, 25 mg/mL Teva Parenteral Medicines, Inc.
ANDA 073617 Pentamidine Isethionate for Injection, 300 mg/vial Baxter Healthcare Corp.
ANDA 073683 Cyclobenzaprine HCl Tablets, 10 mg Sandoz Inc.
ANDA 074013 Pindolol Tablets USP, 5 mg Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26505-4310.
ANDA 074018 Pindolol Tablets USP, 10 mg Do.
ANDA 074105 Naproxen Tablets USP, 250 mg, 375 mg, and 500 mg DAVA Pharmaceuticals, Inc., Parker Plaza, 400 Kelby St., 10th Floor, Fort Lee, NJ 07024.
ANDA 074147 Metoclopramide Injection USP, 5 mg/mL Hospira, Inc.
ANDA 074206 Dobutamine Injection USP, 250 mg (base)/20 mL Teva Parenteral Medicines, Inc.
ANDA 074252 Cimetidine HCl Injection, EQ 300 mg (base)/2 mL Do.
ANDA 074519 Captopril Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mg Sandoz Inc.
ANDA 074613 Bumetanide Injection USP, 0.25 mg/mL Teva Parenteral Medicines, Inc.
ANDA 074616 Inamrinone Lactate Injection, 5 mg/mL Hospira, Inc.
ANDA 074629 Iopamidol Injection USP, 41%, 51%, 61%, and 76% Baxter Healthcare Corp.
ANDA 074637 Iopamidol Injection USP, 61% Hospira, Inc.
ANDA 074753 Atracurium Besylate Injection USP, 10 mg/mL (preserved) Baxter Healthcare Corp.
ANDA 074768 Atracurium Besylate Injection USP, 10 mg/mL (preservative free) Do.
ANDA 074784 Atracurium Besylate Injection USP, 10 mg/mL Teva Parenteral Medicines, Inc.
ANDA 074795 Fluphenazine Decanoate Injection USP, 25 mg/mL Do.
ANDA 074969 Acyclovir for Injection USP, 500 mg/vial and 1,000 mg/vial Do.
ANDA 075004 Diltiazem HCl Injection, 5 mg/mL Hospira, Inc.
ANDA 075005 Iopamidol Injection USP, 51%, 61%, and 76% Do.
ANDA 075012 Etodolac Tablets USP, 400 mg and 500 mg Mylan Pharmaceuticals, Inc.
ANDA 075071 Etodolac Capsules, 200 mg and 300 mg Do.
ANDA 075119 Buspirone HCl Tablet USP, 5 mg, 10 mg, and 15 mg Egis Pharmaceuticals PLC, c/o GlobePharm Inc., 313 Pine St., Suite 204, Deerfield, IL 60015.
NDA 075166 Isosorbide Mononitrate Extended-Release Tablets, 60 mg SkyePharma AG, c/o Compliance Resources, LLC, 7100 Farmington Lane, Hillsborough, NC 27278.
ANDA 075328 Pemoline Tablets, 18.75 mg, 37.5 mg, and 75 mg Vintage Pharmaceuticals, 120 Vintage Dr., Huntsville, AL 35811.
ANDA 075392 Propofol Injectable Emulsion, 10 mg/mL Teva Parenteral Medicines, Inc.
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).



[top] 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