Withdrawal of Approval of 70 New Drug Applications and 97 Abbreviated New Drug Applications:
Federal Register Volume 76, Number 110 (Wednesday, June 8, 2011)
Notices
Pages 33310-33314
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
FR Doc No: 2011-14164
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2011-N-0411
Bristol-Myers Squibb Co. et al.; Withdrawal of Approval of 70 New
Drug Applications and 97 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval of 70 new drug applications (NDAs) and 97 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 Date: July 8, 2011.
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 table 1 of 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 007289.................. Trigesic and
Bristol-Myers Squibb
Trigesic with
Co., P.O. Box 4000,
Codeine Tablets.
Princeton, NJ 08543- 4000.
NDA 008248.................. Wyamine
Baxter Healthcare
(mephentermine
Corp., 2 Esterbrook sulfate) Sulfate
Lane, Cherry Hill,
Injection.
NJ 08003-4099.
NDA 008834.................. Tronothane HCl
Abbott Laboratories,
(pramoxine
Dept. PA76/Bldg. hydrochloride
AP30-1E, 200 Abbott
(HCl)).
Park Rd., Abbott
Park, IL 60064- 6157.
NDA 009182.................. Gantrisin
Hoffman-La Roche,
(sulfisoxazole
Inc., 340 Kingsland acetyl).
St., Nutley, NJ 07110-1199.
NDA 011835.................. Hydrodiuril
Merck & Co., Inc.,
(hydrochlorothiazid P.O. Box 1000, UG2C- e (HCTZ)) Tablets. 50, North Wales, PA 19454.
NDA 011971.................. Oretic (HCTZ)
Abbott Laboratories.
Tablets, 25 milligrams (mg) and 50 mg.
NDA 012302.................. Choloxin
Do.
(dextrothyroxine sodium) Tablets, 1 mg, 2 mg, 4 mg, and 6 mg.
NDA 013402.................. Aldoril (methyldopa/ Merck & Co., Inc.
HCTZ) Tablets.
NDA 015539.................. Serax (oxazepam)
Alpharma U.S.
Capsules and
Pharmaceuticals
Tablets.
Division, c/o King
Pharmaceuticals,
Inc., 501 Fifth
St., Bristol, TN 37620.
NDA 016118.................. Teslac
Bristol-Myers Squibb
(testolactone)
Co.
Tablets.
NDA 016402.................. Alupent
Boehringer
(metaproterenol
Ingelheim, 900 sulfate) Inhalation Ridgebury Rd., P.O.
Aerosol \1\.
Box 368,
Ridgefield, CT 06877-0368.
NDA 016666.................. Hippuran (hippuran I- Mallinckrodt Medical 131) Injection.
Inc., c/o Covidien, 675 McDonnell
Blvd., Hazelwood,
MO 63042.
NDA 016979.................. Megace (megestrol
Bristol-Myers Squibb acetate) Tablets,
Co. 20 mg and 40 mg.
NDA 017015.................. Pavulon (pancuronium Organon USA Inc., c/ bromide) Injection. o Schering-Plough
Corp., 2000
Galloping Hill Rd.,
Kenilworth, NJ 07033-0530.
NDA 017352.................. Fastin (phentermine GlaxoSmithKline,
HCl) Capsules.
P.O. Box 13398,
Five Moore Dr.,
Research Triangle
Park, NC 27709- 3398.
Page 33311
NDA 017628.................. Tolectin (tolmetin
Ortho-McNeil sodium) Tablets,
Pharmaceutical, 200 mg and 600 mg.
Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC, 1125 Trenton-
Harbourton Rd.,
Titusville, NJ 08560-0200.
NDA 017920.................. Tagamet (cimetidine) GlaxoSmithKline.
Tablets, 100 mg, 200 mg, 300 mg, 400 mg, and 800 mg.
NDA 017924.................. Tagamet (cimetidine) Do.
Oral Solution, 300 mg/5 milliliters
(mL).
NDA 017933.................. Lente Iletin
Eli Lilly and Co.,
(insulin zinc
Lilly Corporate suspension purified Center, beef-pork).
Indianapolis, IN 46285.
NDA 017934.................. Similente Iletin
Do.
(insulin zinc suspension purified beef-pork).
NDA 017939.................. Tagamet (cimetidine) GlaxoSmithKline.
Injection, 150 mg/ mL.
NDA 018084.................. Tolectin DS
Ortho-McNeil
(tolmetin sodium)
Pharmaceutical,
Capsules.
Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC.
NDA 018096.................. Dextrose and Sodium Hospira, Inc.
Chloride Injection
USP.
NDA 018118.................. Lanoxicaps (digoxin) GlaxoSmithKline.
Capsules.
NDA 018201.................. Moduretic (amiloride Merck & Co., Inc.
HCl/HCTZ) Tablets.
NDA 018380.................. Sodium Chloride
Do.
Irrigation USP.
NDA 018590.................. Aminocaproic Acid
Baxter Healthcare
Injection USP, 250
Corp. mg/mL.
NDA 018776.................. Norcuron (vecuronium Organon USA Inc., c/ bromide) Injection. o Schering-Plough
Corp.
NDA 018869.................. Nimotop (nimodipine) Bayer Healthcare
Capsules.
Pharmaceuticals,
Inc., P.O. Box 1000, Montville, NJ 07045.
NDA 019008.................. Bretylium Tosylate
Hospira, Inc., 275 in Dextrose
North Field Dr.,
Injection USP.
Bldg. H2, Lake
Forest, IL 60045- 5046.
NDA 019030.................. Bretylium Tosylate
Hospira, Inc.
Injection USP, 50 mg/mL.
NDA 019058.................. Tenormin (atenolol) AstraZeneca
Injection, 5 mg/10
Pharmaceuticals LP, mL.
1800 Concord Pike,
P.O. Box 8355,
Wilmington, DE 19803-89355.
NDA 019091.................. Ismo (isosorbide
Promius Pharma, LLC, mononitrate)
200 Somerset
Tablets, 20 mg.
Corporate Blvd., 7th Floor,
Bridgewater, NJ 08807.
NDA 019165.................. Protamine Zinc
Eli Lilly and Co.
(insulin zinc suspension beef).
NDA 019168.................. Lente Insulin
Do.
(insulin zinc suspension beef).
NDA 019204.................. Cartrol (carteolol
Abbot Laboratories.
HCl) Tablets.
NDA 019377.................. Humulin L (insulin
Do. zinc suspension recombinant human)
Injection.
NDA 019434.................. Tagamet (cimetidine GlaxoSmithKline.
HCl) in Sodium
Chloride Injection,
Equivalent to (EQ) 6 mg Base/mL.
NDA 019546.................. Dynacirc
SmithKline Beecham
(isradipine)
Corp., d/b/a
Capsules.
GlaxoSmithKline,
One Franklin Plaza, 200 North 16th St.,
Philadelphia, PA 19102.
NDA 019561.................. Micro-K LS
KV Pharmaceutical
(potassium
Co., One Corporate chloride).
Woods Dr.,
Bridgeton, MO 63044.
NDA 019571.................. Humulin U (insulin
Eli Lilly and Co. zinc suspension extended recombinant human)
Injection.
NDA 019583.................. Relafen (nabumetone) SmithKline Beecham
Tablets.
Corp., c/o
GlaxoSmithKline, 2301 Renaissance
Blvd., RN210, P.O.
Box 61540, King of
Prussia, PA 19406.
NDA 019591.................. Lariam (mefloquine
Hoffmann-La Roche
HCl) Tablets, 250
Inc. mg.
NDA 019638.................. Arduan (pipecuronium Organon USA Inc., c/ bromide) Injection. o Schering-Plough
Corp.
NDA 019735.................. Floxin (ofloxacin)
Ortho-McNeil-Janssen
Tablets.
Pharmaceuticals,
Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC,
P.O. Box 300, 920
Route 202 South,
Raritan, NJ 08869- 0602.
NDA 019979.................. Ticlid (ticlopidine Roche Palo Alto LLC,
HCl) Tablets.
c/o Hoffmann-La
Roche Inc., 340
Kingsland St.,
Nutley, NJ 07110- 1199.
NDA 020027.................. Cardizen (diltiazem Biovail Technologies
HCl) Injection.
Ltd., On Behalf of
Biovail
Laboratories
International SRL, 700 Route 202/206
North, Bridgewater,
NJ 08807.
NDA 020100.................. Humulin 50/50
Eli Lilly and Co.
(insulin recombinant human and insulin suspension isophane recombinant human).
NDA 020269.................. Dobutamine HCl in 5% Hospira, Inc.
Dextrose Injection.
NDA 020507.................. Teczem (enalapril
Biovail maleate/diltiazem
Technologies, Ltd. maleate) Extended-
Release Tablets.
NDA 020548.................. Flovent (fluticasone GlaxoSmithKline. propionate)
Inhalation Aerosol
\1\.
NDA 020549.................. Flovent (fluticasone Do. propionate)
Inhalation Powder.
NDA 020668.................. Lexxel (enalapril
AstraZeneca maleate and
Pharmaceuticals LP. felodipine)
Extended-Release
Tablets.
NDA 020792.................. Cardizem (diltiazem Biovail
HCl) Injection.
Technologies, Ltd.
NDA 020906.................. Etopophos
Bristol-Myers Squibb
(estoposide
Co. phosphate)
Injection.
NDA 020939.................. Diltiazem HCl
Biovail
Extended-Release
Technologies, Ltd.
Capsules, 120 mg, 180 mg, 240 mg, 300 mg, 360 mg, and 420 mg.
Page 33312
NDA 020961.................. Vitravene
Novartis
(fomivirsen sodium) Pharmaceuticals
Injection.
Corp., One Health
Plaza, East
Hanover, NJ 07936- 1080.
NDA 020966.................. Sporanox
Ortho-McNeil-Janssen
(itraconazole)
Pharmaceuticals,
Injection.
Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC.
NDA 021084.................. Skin Exposure
U.S. Army Medical
Reduction Paste
Material
Against Chemical
Development
Warfare Agent
Activity, c/o
(SERPACWA)
Office of Surgeon
(polyetrafluoroethy General, 1430 lene and
Veterans Dr., Fort perfluoropolymethyl Detrick, MD 21702- isopropyl ether).
9234.
NDA 021088.................. Viadur (leuprolide
Ortho-McNeil-Janssen acetate) Implant.
Pharmaceutical,
Inc., c/o Johnson &
Johnson
Pharmaceutical
Research &
Development, LLC.
NDA 021281.................. Prevacid
Takeda Global
(lansoprazole).
Research and
Development Center,
Inc., One Takeda
Parkway, Deerfield,
IL 60015.
NDA 021435.................. Amvaz (amlodipine
Dr. Reddy's maleate) Tablets,
Laboratories, Inc., 2.5 mg, 5 mg, and
200 Somerset 10 mg.
Corporate Blvd.,
Bldg. II, 7th
Floor, Bridgewater,
NJ 08807-2862.
NDA 021486.................. Lidopel (lidocaine
Empi, Inc., P.O. Box
HCl and
709, Highway 22 epinephrine)
East, Clear Lake,
Solution.
SD 57226.
NDA 021507.................. Prevacid NapraPac
Takeda Global 250, Prevacid
Research and
NapraPac 375, and
Development Center,
Prevacid NapraPac
Inc. 500 (lansoprazole and naproxen)
Tablets.
NDA 021566.................. Prevacid I.V.
Do.
(lansoprazole)
Injection.
NDA 021592.................. Foradil Certihaler
Novartis
(formoterol
Pharmaceuticals fumarate)
Corp.
Inhalation Powder.
NDA 021850.................. Zegerid (omeprazole/ Santarus, Inc., 3721 sodium bicarbonate/ Valley Center Dr., magnesium
suite 400, San hydroxide).
Diego, CA 92130.
ANDA 040013................. Lidocaine HCl
Hospira, Inc.
Injection USP, 1%.
ANDA 040073................. Naphazoline HCl
Bausch & Lomb, Inc.,
Ophthalmic Solution 7 Giralda Farms,
USP, 0.1%.
suite 1001,
Madison, NJ 07940.
ANDA 040095................. Heparin Sodium
Hospira, Inc.
Injection USP, 10,000 Units/mL.
ANDA 040224................. Chlorpromazine HCl
Pharmaceutical
Oral Concentrate
Associates, Inc.,
USP, 100 mg/mL.
201 Delaware St.,
Greenville, SC 29605.
ANDA 040360................. Perphenazine Oral
Do.
Solution USP, 16 mg/ 5 mL.
ANDA 040522................. Norepinephrine
Metrics
Bitartrate
Pharmaceuticals
Injection USP, EQ 1 Ventures, LLC, c/o mg (base)/1 mL.
Pharmaforce Inc., 960 Crupper Ave.,
Columbus, OH 43229.
NDA 050521.................. Ceclor (cefaclor)
Eli Lilly and Co.
Capsules, 250 mg and 500 mg.
NDA 050522.................. Ceclor (cefaclor)
Do.
Suspension.
NDA 050560.................. Cefizox (ceftizoxime Astellas Pharma US, sodium) Powder for
Inc., 3 Parkway
Injection.
North, Deerfield,
IL 60015.
ANDA 061394................. Principen
Apothecon, Inc., c/o
(ampicillin for
Bristol-Myers oral suspension
Squibb Co., P.O.
USP).
Box 4000,
Princeton, NJ 08543- 4000.
ANDA 061886................. Trimox (amoxicillin Do. for oral suspension
USP), 50 mg/mL, 125 mg/5 mL, and 250 mg/ 5 mL.
ANDA 062336................. Mutamycin (mitomycin Bristol-Myers Squibb for injection USP)
Co. 5 mg, 20 mg, and 40 mg Vials.
ANDA 062557................. Kefzol (cefazolin
Eli Lilly and Co. sodium for injection USP).
ANDA 062563................. Erythromycin
Elkins-Sinn, Inc., c/
Lactobionate for
o Baxter Healthcare
Injection USP.
Corp., 2 Esterbrook
Lane, Cherry Hill,
NJ 08003-4002.
ANDA 062885................. Trimox (amoxicillin Apothecon, Inc., c/o for oral suspension Bristol-Myers
USP), 125 mg/5 mL
Squibb Co. and 250 mg/5 mL.
ANDA 062993................. Erythromycin
Baxter Healthcare
Lactobionate for
Corp.
Injection USP, EQ 500 mg (base) and 1 gram (g) (base)
Vials.
ANDA 063294................. Cefizox (ceftizoxime Astellas Pharma US, for injection USP), Inc., Three Parkway
EQ 1 g (base) and 2 North, Deerfield, g (base) Vials.
IL 60015-2548.
ANDA 070225................. Verapamil HCl
Luitpold
Injection USP, 2.5
Pharmaceuticals, mg/mL.
Inc., One Luitpold
Dr., P.O. Box 9001,
Shirley, NY 11967.
ANDA 070231................. Carbamazepine
Inwood Laboratories,
Tablets USP, 200 mg. Inc., Subsidiary of
Forest
Laboratories, Inc.,
Harborside
Financial Center,
Plaza Three, suite 602, Jersey City,
NJ 07311.
ANDA 070291................. Methyldopate HCl
Baxter Healthcare
Injection USP, 50
Corp. mg/mL.
ANDA 070617................. Verapamil HCl
Luitpold
Injection USP, 2.5
Pharmaceuticals, mg/mL.
Inc.
ANDA 070891................. Bretylium Tosylate
Do.
Injection USP, 50 mg/mL.
ANDA 072058................. Pancuronium Bromide Elkins-Sinn, Inc., c/
Injection, 1 mg/mL. o Baxter Healthcare
Corp.
ANDA 072059................. Pancuronium Bromide Do.
Injection, 2 mg/mL.
ANDA 072060................. Pancuronium Bromide Do.
Injection, 2 mg/mL.
ANDA 072272................. Droperidol Injection Hospira, Inc.
USP, 2.5 mg/mL.
ANDA 072335................. Droperidol Injection Luitpold
USP, 2.5 mg/mL.
Pharmaceuticals,
Inc.
ANDA 074188................. Dipivefrin HCl
Bausch & Lomb, Inc.
Ophthalmic Solution
USP, 0.1%.
ANDA 074320................. Etoposide Injection, Hospira, Inc. 20 mg/mL.
ANDA 074351................. Etoposide Injection, Do. 20 mg/mL.
ANDA 074353................. Cimetidine HCl
Luitpold
Injection USP.
Pharmaceuticals,
Inc.
Page 33313
ANDA 074381................. Dobutamine Injection Baxter Healthcare
USP, 12.5 mg (base)/ Corp. mL.
ANDA 074545................. Dobutamine Injection Luitpold
USP, 12.5 mg/mL.
Pharmaceuticals,
Inc.
ANDA 074634................. Dobutamine Injection Hospira, Inc.
USP, 12.5 mg/mL.
ANDA 074643................. Minoxidil Topical
Bausch & Lomb, Inc.
Solution, 2%.
ANDA 074743................. Minoxidil Topical
Sight
Solution, 2%.
Pharmaceuticals,
Inc., 7 Giralda
Farms, suite 1001,
Madison, NJ 07940.
ANDA 074824................. Atracurium Besylate Baxter Healthcare
Injection USP, 10
Corp. mg/mL.
ANDA 074825................. Atracurium Besylate Do.
Injection USP, 10 mg/mL.
ANDA 075341................. Ketoconazole Tablets AAIPharma Service
USP, 200 mg.
Corp., 2320
Scientific Park
Dr., Wilmington, NC 28405.
ANDA 075456................. Enalaprilat
Hospira, Inc.
Injection, 1.25 mg/ mL.
ANDA 075542................. Amrinone (inamrinone Baxter Healthcare injection USP) EQ 5 Corp. mg/mL.
ANDA 076617................. Fluconazole in
Hospira, Inc.
Sodium Chloride 0.9% Injection.
ANDA 076656................. Fenoldopam Mesylate Luitpold
Injection USP, EQ
Pharmaceuticals, 10 mg (base)/mL.
Inc.
ANDA 076695................. Ondansetron
Hospira, Inc.
Injection USP, EQ 2 mg (base)/mL.
ANDA 076696................. Ondansetron
Do.
Injection USP, EQ 2 mg (base)/mL.
ANDA 077065................. Terbinafine HCl
Gedeon Richter PLC,
Tablets, EQ 250 mg c/o Gedeon Richter
(base).
USA, Inc., 1200
East Ridgewood
Ave., Ridgewood, NJ 07450.
ANDA 077333................. Amlodipine Besylate Do.
Tablets, EQ 2.5 mg
(base), 5 mg
(base), and 10 mg
(base).
ANDA 077389................. Carboplatin
Teva Parenteral
Injection.
Medicines, Inc., 19
Hughes, Irvine, CA 92618.
ANDA 077392................. Lamotrigine Tablets, Roxane Laboratories, 25 mg, 100 mg, 150, Inc., 1809 Wilson mg, and 200 mg.
Rd., Columbus, OH 43228.
ANDA 077994................. Ironotecan HCl
Sandoz, Inc., 2555
Injection.
West Midway Blvd.,
Broomfield, CO 80038-0446.
ANDA 080416................. Procaine HCl
Hospira, Inc.
Injection USP, 1% and 2%.
ANDA 083346................. Isoproterenol HCl
Do.
Injection USP, 0.2 mg/mL.
ANDA 084178................. Methyltestosterone
KV Pharmaceutical
Tablets, 5 mg.
Co., One Corporate
Woods Dr.,
Bridgeton, MO 63044.
ANDA 084179................. Methyltestosterone
Do.
Tablets, 25 mg.
ANDA 084312................. Methyltestosterone
Do.
Tablets, 10 mg.
ANDA 084767................. Dimenhydrinate
Baxter Healthcare
Injection USP.
Corp.
ANDA 085284................. Aminophylline
KV Pharmaceutical
Tablets, 100 mg.
Co.
ANDA 085285................. Secobarbital Sodium Do.
Capsules, 100 mg.
ANDA 085289................. Aminophylline
Do.
Tablets, 200 mg.
ANDA 085363................. Acetaminophen and
Do.
Codeine Phosphate
Tablets, 325 mg/45 mg.
ANDA 085384................. Triprolidine HCl
Do.
Syrup, 1.25mg/5 mL.
ANDA 085385................. Promethazine HCl
Do.
Syrup, 25 mg/5 mL.
ANDA 085388................. Promethazine HCl
Do.
Syrup, 6.25 mg/5 mL.
ANDA 085466................. Brompheniramine
Do.
Maleate Elixir, 2 mg/5 mL.
ANDA 085492................. Acetic Acid with
Do.
Hydrocortisone Otic
Solution, 2%/1%.
ANDA 085493................. Acetic Acid Otic
Do.
Solution, 2%.
ANDA 085551................. Hydroxyzine HCl
Baxter Healthcare
Injection USP, 25
Corp. mg/mL and 50 mg/mL.
ANDA 085621................. Diphenhydramine HCl KV Pharmaceutical
Elixir, 12.5 mg/5
Co. mL.
ANDA 085810................. Prednisone Tablets, Do. 5 mg.
ANDA 086619................. Hydrocortisone
Baxter Healthcare
Sodium Succinate
Corp. for Injection USP,
EQ 100 mg (base)/
Vial.
ANDA 086661................. Donnatal
A.H. Robins Co., c/o
(phenobarbital,
Wyeth hyoscyamine
Pharmaceuticals, sulfate, atropine
Inc., P.O. Box sulfate,
8299, Philadelphia, scopolamine (HBr))
PA 19101-8299.
Elixir.
ANDA 086676................. Donnatal
Do.
(phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine (HBr))
Tablets.
ANDA 086677................. Donnatal
Do.
(phenobarbital, hyoscyamine sulfate, atropine sulfate, scopolamine (HBr))
Capsules.
ANDA 086797................. Novocain (procaine
Hospira, Inc.
HCl injection USP) 10%.
ANDA 086906................. Methylprednisolone
Elkins-Sinn, Inc., c/
Sodium Succinate
o Baxter Healthcare for Injection USP,
Corp.
EQ 40 mg (base), 125 mg (base), 500 mg (base), and 1 g
(base) Vials.
ANDA 087239................. Aminophylline
Do.
Injection USP, 25 mg/mL.
ANDA 087240................. Aminophylline
Luitpold
Injection USP, 25
Pharmaceuticals, mg/mL.
Inc.
ANDA 087311................. Chlorthalidone
KV Pharmaceutical
Tablets, 25 mg.
Co.
ANDA 087312................. Chlorthalidone
Do.
Tablets, 50 mg.
ANDA 087506................. Muro Opcon
Bausch & Lomb, Inc.
(naphazoline HCl ophthalmic solution
USP, 0.1%).
ANDA 087567................. Hydrocortisone
Baxter Healthcare
Sodium Succinate
Corp. for Injection USP,
EQ 250 mg (base)/
Vial.
ANDA 087568................. Hydrocortisone
Do.
Sodium Succinate for Injection USP,
EQ 500 mg (base)/
Vial.
Page 33314
ANDA 087569................. Hydrocortisone
Do.
Sodium Succinate for Injection USP,
EQ 1 g (base)/Vial.
ANDA 087584................. Potassium Chloride
Luitpold for Injection
Pharmaceuticals,
Concentrate USP.
Inc.
ANDA 087601................. Aminophylline
Hospira, Inc.
Injection USP, 25 mg/mL.
ANDA 087956................. Vitamin K1
Do.
(phytonadione injection emulsion
USP), 10 mg/mL.
ANDA 088279................. Meperidine HCl
Baxter Healthcare
Injection USP, 25
Corp. mg/mL.
ANDA 088280................. Meperidine HCl
Do.
Injection USP, 50 mg/mL.
ANDA 088281................. Meperidine HCl
Do.
Injection USP, 75 mg/mL.
ANDA 088282................. Meperidine HCl
Do.
Injection USP, 100 mg/mL.
ANDA 088326................. Lidocaine HCl
Hospira, Inc.
Injection USP, 1.5%.
ANDA 088331................. Lidocaine HCl
Do.
Injection USP, 2%.
ANDA 088368................. Lidocaine HCl
Do.
Injection USP, 20%.
ANDA 088371................. Cyclophosphamide for Baxter Healthcare
Injection USP, 100
Corp. mg/Vial.
ANDA 088372................. Cyclophosphamide for Do.
Injection USP, 200 mg/Vial.
ANDA 088373................. Cyclophosphamide for Do.
Injection USP, 500 mg/Vial.
ANDA 088374................. Cyclophosphamide for Do.
Injection USP, 1 g/
Vial.
ANDA 089649................. Lidocaine HCl and
Hospira, Inc.
Epinephrine
Injection.
ANDA 089703................. Prochlorperazine
Do.
Edisylate Injection
USP, EQ 5 mg (base)/ mL.
ANDA 089707................. Perphenazine Tablets Ivax Pharmaceuticals
USP, 2 mg.
Inc., 400 Chestnut
Ridge Rd.,
Woodcliff Lake, NJ 07677.
ANDA 090954................. Cromolyn Sodium Oral Pack
Solution
Pharmaceuticals,
Concentrate, 100 mg/ LLC, 1110 West Lake 5 mL.
Cook Rd., suite 152, Buffalo Grove,
IL 60089.
\1\ This product was an oral pressurized metered-dose inhaler that contained chlorofluorocarbons (CFCs) as a propellant. CFCs may no longer be used as a propellant for any metaproterenol sulfate or fluticasone propionate metered-dose inhalers (see 75 FR 19213-19241,
April 14, 2010; 71 FR 70870-70873, December 7, 2006).
Therefore, under section 505(e) of the Federal Food, Drug, and
Cosmetic Act (the 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 of Food and Drugs, approval of the applications listed in table 1 of this document, and all amendments and supplements thereto, is hereby withdrawn, effective July 8, 2011. 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 of this document that are in inventory on the date that this notice becomes effective (see the DATES section) 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: May 31, 2011.
Janet Woodcock,
Director, Center for Drug Evaluation and Research.
FR Doc. 2011-14164 Filed 6-7-11; 8:45 am
BILLING CODE 4160-01-P
