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Notice

Bracco Diagnostics et al.; Withdrawal of Approval of 52 New Drug Applications and 77 Abbreviated New Drug Applications

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Start Preamble

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in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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

Start Further Info

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.

End Further Info End Preamble Start Supplemental Information

SUPPLEMENTARY INFORMATION:

The holders of the applications listed in Start Printed Page 43211table 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.

Table 1

Application No.DrugApplicant
NDA 011620Cardiografin (diatrizoate meglumine USP, 85%) InjectionBracco Diagnostics, 107 College Rd. East, Princeton, NJ 08540.
NDA 012828Travase (sutilains) OintmentAbbott Laboratories, PA 77/Bldg. AP30-1E, 200 Abbott Park Rd., Abbott Park, IL 60064-6157.
NDA 014215Celestone (betamethasone) Oral SolutionMerck Sharp & Dohme Corp., One Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889.
NDA 014685Aventyl (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 014860Aralen Phosphate (chloroquine phosphate) with primaquine phosphate TabletsSanofi-Aventis U.S., LLC, 55 Corporate Dr., Bridgewater, NJ 08807-0890.
NDA 016017Cloroquine-Primaquine (chloroquine phosphate and primaquine phosphate) TabletsDo.
NDA 016019Questran Resin (cholestyramine resin)Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543-4000.
NDA 016640Questran Powder (cholestyramine for oral suspension)Do.
NDA 016721Dalmane (flurazepam HCl) CapsulesValeant Pharmaceuticals North America, LLC, 700 Route 202/206 North, Bridgewater, NJ 08807.
NDA 016732Talwin 50 (pentazocine HCl USP), Tablets, 50 mgSanofi-Aventis U.S., LLC.
NDA 016891Talwin Compound (pentazocine HCl USP and aspirin USP), Equivalent to (EQ) 12.5 mg (base) and 325 mgDo.
NDA 016927Demulen 1/50-21 (ethynodiol diacetate/ethinyl estradiol) TabletsG.D. Searle, LLC, c/o Pfizer Inc., 235 East 42nd St., New York, NY 10017.
NDA 016936Demulen 1/50-28 (ethynodiol diacetate/ethinyl estradiol) TabletsDo.
NDA 017557Danocrine (danazol) CapsulesSanofi-Aventis U.S., LLC.
NDA 017633Glycine Irrigation USP, 1.5%Hospira, Inc., 275 North Field Dr., Lake Forest, IL 60045.
NDA 017821Flexeril (cyclobenzaprine HCl) Tablets, 5 mg and 10 mgJanssen Research & Development, LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ 08560.
NDA 017850Klotrix (potassium chloride) Extended-Release TabletsBristol-Myers Squibb Co.
NDA 017857Stadol (butorphanol tartrate USP) InjectionDo.
NDA 018160Demulen 1/35-28 (ethynodiol diacetate/ethinyl estradiol) TabletsG.D. Searle, LLC, c/o Pfizer Inc.
NDA 018168Demulen 1/35-21 (ethynodiol diacetate/ethinyl estradiol) TabletsDo.
ANDA 018398Dopamine HCl Injection USP, 40 mg/mL and 80 mg/mLBaxter Healthcare Corp., 25212 W. Illinois Route 120, Round Lake, IL 60073.
NDA 018458Talacen (pentazocine HCl USP and acetaminophen USP), Tablets, EQ 25 mg (base) and 650 mgSanofi-Aventis U.S., LLC.
ANDA 018581Sodium Nitroprusside for Injection USP, 50 mg/vialBaxter Healthcare Corp.
NDA 018733Talwin Nx (pentazocine HCl and naloxone HCl) Tablets, 50 mg and 0.5 mgSanofi-Aventis U.S., LLC.
NDA 018981Enkaid (encainide HCl) CapsulesBristol-Myers Squibb Co.
NDA 019057Hytrin (terazosin HCl) Tablets, 1 mg, 2 mg, 5 mg, and 10 mgAbbott Laboratories.
NDA 019436Primacor (milrinone lactate) Injection, EQ 1 mg (base)/mLSanofi-Aventis U.S., LLC.
NDA 019507Kerlone (betaxolol HCl) Tablets, 10 mg and 20 mgDo.
NDA 019578Mefloquine HCl Tablets, 250 mgU.S. Army Office of the Surgeon General, Department of the Army, 1430 Veterans Dr., Fort Detrick, MD 21702-5009.
NDA 019669Questran Light, Questran II, and Questran Sugar Free (cholestyramine for oral suspension)Bristol-Myers Squibb Co.
NDA 019807Kerledex (betaxolol HCl and chlorthalidone) TabletsSanofi-Aventis U.S., LLC.
NDA 019977Oramorph SR (morphine sulfate) Sustained-Release Tablets, 15 mg, 30 mg, 60 mg, and 100 mgXanodyne Pharmaceuticals, Inc., One Riverfront Pl., Newport, KY 41071.
NDA 020036Aredia (pamidronate disodium) for injection, 30 mg, 60 mg, and 90 mgNovartis Pharmacueticals Corp., One Health Plaza, East Hanover, NJ 07936-1080.
NDA 020038Fludara (fludarabine phosphate) for Injection, 50 mg/vialGenzyme Corp., 500 Kendall St., Cambridge, MA 02142.
NDA 020056Atropine Sulfate Aerosol for InhalationU.S. Army Office of the Surgeon General.
NDA 020070Cognex (tacrine HCl) Capsules, 10 mg, 20 mg, 30 mg, and 40 mgShionogi Inc., 300 Campus Dr., Florham Park, NJ 07932.
NDA 020095Zantac (ranitidine HCl) Geldose CapsulesGlaxoSmithKline, P.O. Box 13398, 5 Moore Dr., Research Triangle Park, NC 27709.
NDA 020151Effexor (venlafaxine HCl) Tablets, 12.5 mg, 25 mg, 37.5 mg, 50 mg, 75 mg, and 100 mgWyeth Pharmaceuticals, Inc., 235 East 42nd St., New York, NY 10017.
NDA 020239Kytril (granisetron HCl) Injection, EQ 1 mg (base)/mL and 0.1 mg (base)/mL, 1 mg (base)/mL, and 3 mg (base)/mLHoffman-La Roche, Inc., c/o Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080.
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NDA 020305Kytril (granisetron HCl) Tablets, EQ 1 mg (base), EQ 2 mg (base)Do.
NDA 020336DynaCirc CR (isradipine) Controlled-Release TabletsGlaxoSmithKline, 2301 Renaissance Blvd., King of Prussia, PA 19406.
NDA 020343Primacor (milrinone lactate) InjectionSanofi-Aventis U.S., LLC.
NDA 020347Hytrin (terazosin HCl) Capsules, 1 mg, 2 mg, 5, mg, and 10 mgAbbott Laboratories.
NDA 020441Pulmicort Turbuhaler (budesonide) Inhalation PowderAstraZeneca, 1800 Concord Pike, P.O. Box 8355, Wilmington, DE 19803-8355.
NDA 020484Innohep (tinzaparin sodium) InjectionLEO Pharma A/S, c/o Parexel International Corp., 4600 East-West Highway, Suite 350, Bethesda, MD 20814.
NDA 020611Dovonex (calcipotriene) Topical Solution, 0.005%LEO Pharma A/S, c/o LEO Pharma Inc., 1 Sylvan Way, Parsippany, NJ 07054.
NDA 020680Norvir (ritonavir) Capsules, 100 mgAbbott Laboratories.
NDA 021238Kytril (granisetron HCl) Oral Solution, 2 mg/10 mLHoffman-La Roche, Inc., c/o Genentech, Inc.
NDA 021320Plenaxis (abarelix) Injection, 100 mg/vialSpecialty European Pharma Limited, c/o Strategic Bioscience Corp., 93 Birch Hill Rd., Stow, MA 01775.
NDA 021744Proquin XR (ciprofloxacin HCl) Tablets, 500 mgDepomed Inc., 1360 O'Brien Dr., Menlo Park, CA 94025.
NDA 022021Altace (ramipril) Tablets, 1.25 mg, 2.5 mg, 5 mg, and 10 mgKing Pharmaceuticals Inc., c/o Pfizer Inc., 235 East 42nd St., New York, NY 10017.
NDA 022026Amlodipine Besylate Orally Disintegrating Tablets, 2.5 mg, 5 mg, and 10 mgSynthon Pharmaceuticals, Inc., 9000 Development Dr., P.O. Box 110487, Research Triangle Park, NC 27709.
NDA 022456Omeprazole, Sodium Bicarbonate, and Magnesium Hydroxide TabletsSantarus, Inc., 3721 Valley Centre Dr., Suite 400, San Diego, CA 92130.
ANDA 040015Neosar (cyclophosphamide) for Injection, 100 mg, 200 mg, 500 mg, 1 gram (gm), and 2 gm vialsTeva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA 92618.
ANDA 040079Thiamine HCl Injection USP, 100 mg/mLHospira, Inc.
ANDA 040131Edrophonium Chloride Injection, 10 mg/mLDo.
ANDA 040162Prochlorperazine Maleate Tablets USP, 5 mg and 10 mgIVAX Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 040272Oxycodone and Acetaminophen Tablets USP, 5 mg/325 mgDuramed Pharmaceuticals, Inc., Subsidiary of Barr Laboratories, Inc., Indirect Wholly Owned Subsidiary of Teva Pharmaceuticals USA, 400 Chestnut Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 040332Leucovorin Calcium Injection USP, 10 mg (base)Teva Parenteral Medicines, Inc.
ANDA 040364Prednisolone Syrup, 15 mg/5 mLNesher Pharmaceuticals (USA) LLC, 13910 Saint Charles Rock Rd., Bridgton, MO 63044.
ANDA 040373Hydralazine HCl Injection USP, 20 mg/mLTeva Parenteral Medicines, Inc.
ANDA 040423Prednisolone Syrup, 5 mg/5 mLNesher Pharmaceuticals (USA) LLC.
ANDA 040505Prochlorperazine Edisylate Injection USP, 5 mg/mLTeva Parenteral Medicines, Inc.
ANDA 040641Methylprednisolone Sodium Succinate for Injection USP, 125 mg/vial, 500 mg/vial, and 1 gm/vialBedford Laboratories, 300 Northfield Rd., Bedford, OH 44146.
ANDA 040662Methylprednisolone Sodium Succinate for Injection USP, 40 mg/vialDo.
ANDA 040709Methylprednisolone Sodium Succinate for Injection USP, 500 mg/vial and 1 gm/vialDo.
ANDA 040795Benzonatate Capsules USP, 100 mg and 200 mgNesher Pharmaceuticals (USA) LLC.
ANDA 040909Sodium Polystyrene Sulfonate Powder for Suspension, 454 gm/bottleCitrus Pharma, LLC, 3940 Quebec Ave. North, Minneapolis, MN 55427.
NDA 050261Declomycin (demeclocycline HCl) Tablets, 75 mg, 150 mg, and 300 mgCorePharma, LLC, 215 Wood Ave., Middllesex, NJ 08846-2554.
ANDA 060003V-Cillin K (pencillin V potassium tablets USP), 125 mg, 250 mg, and 500 mgEli Lilly and Co., Lilly Corporate Center, Indianapolis, IN 46285.
ANDA 060517Fugizone (amphotericin B) for InjectionBristol-Myers Squibb Co.
ANDA 060575Mycostatin (nystatin) Cream, 100,000 units/gmDo.
ANDA 061901Kantrex (kanamycin sulfate injection USP) Injection,75 mg/2 mL, 500 mg/2 mL, and 1 gm/3 mLSandoz Inc., 2555 W. Midway Blvd., Broomfield, CO 80038-0446.
ANDA 062008Nebcin (tobramycin for injection USP)Eli Lilly and Co.
ANDA 062311Amikin (amikacin sulfate injection USP), 50 mg/mL and 250 mg/mLBrisol-Myers Squibb Co.
ANDA 062707Nebcin (tobramycin for injection USP)Eli Lilly and Co.
ANDA 063041Clindamycin Injection USPTeva Parenteral Medicines, Inc.
ANDA 063080Tobramycin Injection USPHospira, Inc.
ANDA 063149Gentamicin Injection USP, 10 mg/mLTeva Parenteral Medicines, Inc.
ANDA 063282Clindamycin Phosphate Injection, EQ 150 mg (base)/mLDo.
ANDA 063253Erythromycin Lactobionate for Injection USP, 500 mg (base)/vial and 1 gm (base)/vialDo.
ANDA 064021Tobramycin Sulfate InjectionBristol-Myers Squibb Co.
Amphotericin B for Injection USP, 50 mg/vialTeva Parenteral Medicines, Inc.
ANDA 064212Daunorubicin HCl for Injection USP, 20 mg (base)/vial and 50 mg (base)/vialDo.
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ANDA 065037Idarubicin HCl for Injection USP, 5 mg/vial, 10 mg/vial, and 20 mg/vialDo.
ANDA 065321Nystatin Topical Powder USP, 100,000 units/gmNesher Pharmaceuticals (USA) LLC.
ANDA 065433Mycophenolate Mofetil Capsules, 250 mgZydus Pharmaceuticals (USA) Inc., 73 Route 31 North, Pennington, NJ 08534.
ANDA 065477Mycophenolate Mofetil Tablets, 500 mgDo.
ANDA 070159Tolazamide Tablets USP, 100 mgPar Pharmaceutical, Inc., One Ram Ridge Rd., Spring Valley, NY 10977.
ANDA 070160Tolazamide Tablets USP, 250 mgDo.
ANDA 070161Tolazamide Tablets USP, 500 mgDo.
ANDA 070431Valproic Acid Capsules, 250 mgDo.
ANDA 070577Verapamil HCl Injection USP, 2.5 mg/mLHospira, Inc.
ANDA 070818Ibuprofen Tablets USP, 400 mgOhm Laboratories, c/o Ranbaxy Inc., 600 College Rd. East, Princeton, NJ 08540.
ANDA 070980Potassium Chloride Extended-Release Capsules USP, 10 milliequivalentsNesher Pharmaceuticals (USA) LLC.
ANDA 071200Disopyramide Phosphate Extended-Release Capsules USP, 150 mgDo.
ANDA 071726Metaproterenol Sulfate Inhalation Solution, 0.6%Nephron Pharmaceuticals Corp., 4121 South West 34th St., Orlando, FL 32811.
ANDA 071855Metaproterenol Sulfate Inhalation Solution, 0.4%Do.
ANDA 072273Albuterol Inhalation Aerosol1Armstrong Pharmaceuticals, Inc. 25 John Rd., Canton, MA 02021.
ANDA 072437Fenoprofen Calcium Capsules USP, 200 mgPar Pharmaceuticals, Inc.
ANDA 072974Methyldopate HCl Injection USPTeva Parenteral Medicines, Inc.
ANDA 073000Dopamine HCl Injection USP, 80 mg/mLDo.
ANDA 073117Metoclopramine Injection USP, 5 mg/mLHospira, Inc.
ANDA 073465Sodium Nitroprusside Injection, 25 mg/mLTeva Parenteral Medicines, Inc.
ANDA 073617Pentamidine Isethionate for Injection, 300 mg/vialBaxter Healthcare Corp.
ANDA 073683Cyclobenzaprine HCl Tablets, 10 mgSandoz Inc.
ANDA 074013Pindolol Tablets USP, 5 mgMylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV 26505-4310.
ANDA 074018Pindolol Tablets USP, 10 mgDo.
ANDA 074105Naproxen Tablets USP, 250 mg, 375 mg, and 500 mgDAVA Pharmaceuticals, Inc., Parker Plaza, 400 Kelby St., 10th Floor, Fort Lee, NJ 07024.
ANDA 074147Metoclopramide Injection USP, 5 mg/mLHospira, Inc.
ANDA 074206Dobutamine Injection USP, 250 mg (base)/20 mLTeva Parenteral Medicines, Inc.
ANDA 074252Cimetidine HCl Injection, EQ 300 mg (base)/2 mLDo.
ANDA 074519Captopril Tablets, 12.5 mg, 25 mg, 50 mg, and 100 mgSandoz Inc.
ANDA 074613Bumetanide Injection USP, 0.25 mg/mLTeva Parenteral Medicines, Inc.
ANDA 074616Inamrinone Lactate Injection, 5 mg/mLHospira, Inc.
ANDA 074629Iopamidol Injection USP, 41%, 51%, 61%, and 76%Baxter Healthcare Corp.
ANDA 074637Iopamidol Injection USP, 61%Hospira, Inc.
ANDA 074753Atracurium Besylate Injection USP, 10 mg/mL (preserved)Baxter Healthcare Corp.
ANDA 074768Atracurium Besylate Injection USP, 10 mg/mL (preservative free)Do.
ANDA 074784Atracurium Besylate Injection USP, 10 mg/mLTeva Parenteral Medicines, Inc.
ANDA 074795Fluphenazine Decanoate Injection USP, 25 mg/mLDo.
ANDA 074969Acyclovir for Injection USP, 500 mg/vial and 1,000 mg/vialDo.
ANDA 075004Diltiazem HCl Injection, 5 mg/mLHospira, Inc.
ANDA 075005Iopamidol Injection USP, 51%, 61%, and 76%Do.
ANDA 075012Etodolac Tablets USP, 400 mg and 500 mgMylan Pharmaceuticals, Inc.
ANDA 075071Etodolac Capsules, 200 mg and 300 mgDo.
ANDA 075119Buspirone HCl Tablet USP, 5 mg, 10 mg, and 15 mgEgis Pharmaceuticals PLC, c/o GlobePharm Inc., 313 Pine St., Suite 204, Deerfield, IL 60015.
NDA 075166Isosorbide Mononitrate Extended-Release Tablets, 60 mgSkyePharma AG, c/o Compliance Resources, LLC, 7100 Farmington Lane, Hillsborough, NC 27278.
ANDA 075328Pemoline Tablets, 18.75 mg, 37.5 mg, and 75 mgVintage Pharmaceuticals, 120 Vintage Dr., Huntsville, AL 35811.
ANDA 075392Propofol Injectable Emulsion, 10 mg/mLTeva 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).

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 Start Printed 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.

Start Signature

Dated: July 15, 2013.

Janet Woodcock,

Director, Center for Drug Evaluation and Research.

End Signature End Supplemental Information

[FR Doc. 2013-17324 Filed 7-18-13; 8:45 am]

BILLING CODE 4160-01-P