[Federal Register Volume 83, Number 36 (Thursday, February 22, 2018)]
[Notices]
[Pages 7738-7740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03607]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0508]


Parke-Davis, Subsidiary of Pfizer, Inc. et al.; Withdraw of 
Approval of 38 New Drug Applications and 43 Abbreviated 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 38 new drug applications (NDAs) and 43 
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of the applications be withdrawn.

DATES: Approval is withdrawn as of March 26, 2018.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.

                                 Table 1
------------------------------------------------------------------------
    Application No.                Drug                  Applicant
------------------------------------------------------------------------
NDA 010151.............  Dilantin (phenytoin      Parke-Davis,
                          sodium) Injection USP,   Subsidiary of Pfizer,
                          50 milligrams (mg)/      Inc., 235 East 42nd
                          milliliter (mL).         St., New York, NY
                                                   10017.
NDA 011903.............  Zolyse (chymotrypsin)    Alcon Laboratories,
                          for Ophthalmic           Inc., 6201 S.
                          Solution, 750 units/     Freeway, TC-45, Fort
                          vial.                    Worth, TX 76134-2099.
NDA 012125.............  Carbocaine (mepivacaine  Hospira Inc., 8401 W.
                          hydrochloride (HCl))     102nd St., Pleasant
                          Injection USP, 3%.       Prairie, WI 53158.
                         Carbocaine with Neo-
                          Cobefrin (mepivacaine
                          HCl; levonordefrin)
                          Injection USP, 2%;
                          0.05 mg/mL.
NDA 012516.............  Sansert (methysergide    Novartis
                          maleate) Tablets, 2 mg.  Pharmaceuticals
                                                   Corp., One Health
                                                   Pl., East Hanover, NJ
                                                   07936-1080.
NDA 016774.............  Serentil (mesoridazine    Do.
                          besylate) Tablets,
                          Equivalent to (EQ) 10
                          mg base, 25 mg base,
                          50 mg base, and 100 mg
                          base.
NDA 016775.............  Serentil (mesoridazine    Do.
                          besylate) Injection,
                          EQ 25 mg base/mL.
NDA 016793.............  Cytosar-U (cytarabine)   Teva Pharmaceuticals
                          for Injection USP, 100   USA, Inc., 425 Privet
                          mg/vial, 500 mg/vial,    Rd., Horsham, PA
                          1 gram (g)/vial, and 2   19044.
                          g/vial.
NDA 016997.............  Serentil (mesoridazine   Novartis
                          besylate) Oral           Pharmaceuticals Corp.
                          Concentrate, EQ 25 mg
                          base/mL.
NDA 017364.............  Aquatensen               Meda Pharmaceuticals,
                          (methyclothiazide)       Inc., 265 Davidson
                          Tablets USP, 5 mg.       Ave., Suite 400,
                                                   Somerset, NJ 08873.
NDA 017575.............  DTIC-Dome (dacarbazine)  Bayer Healthcare
                          for Injection, 100 mg/   Pharmaceuticals,
                          vial and 200 mg/vial.    Inc., 100 Bayer
                                                   Blvd., Whippany, NJ
                                                   07981.
NDA 017717.............  Gyne-Lotrimin            Bayer HealthCare, LLC,
                          (clotrimazole) Vaginal   100 Bayer Blvd., P.O.
                          Tablets, 100 mg.         Box 915, Whippany, NJ
                                                   07981-0915.
NDA 017869.............  Funduscein-25            Novartis
                          (fluorescein sodium)     Pharmaceuticals Corp.
                          Injection, 25%.
NDA 017993.............  Hydergine (ergoloid       Do.
                          mesylates) Tablets,
                          0.5 mg and 1 mg.
NDA 018052.............  Gyne-Lotrimin            Bayer HealthCare, LLC.
                          (clotrimazole) Vaginal
                          Cream, 1%.
NDA 018128.............  Ovcon-50 (norethindrone  Warner Chilcott Co.,
                          and ethinyl estradiol)   LLC, c/o Warner
                          Tablets USP (21-Day      Chilcott (US), LLC,
                          Regimen), 1 mg and       100 Enterprise Dr.,
                          0.05 mg.                 Rockaway, NJ 07866.
NDA 018397.............  Chlor-Trimeton           Bayer HealthCare, LLC.
                          (chlorpheniramine
                          maleate and
                          pseudoephedrine
                          sulfate) Extended-
                          Release Tablets, 8 mg
                          and 120 mg.
NDA 018418.............  Hydergine (ergoloid      Novartis
                          mesylates) Oral          Pharmaceuticals Corp.
                          Solution, 1 mg/mL.
NDA 018439.............  Multi-Vitamins           Watson Laboratories,
                          Concentrate for          Inc., Subsidiary of
                          Infusion, Injection.     Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
NDA 018471.............  Ocuclear (oxymetazoline  Bayer HealthCare, LLC.
                          HCl) Ophthalmic
                          Solution, 0.025%.
NDA 018517.............  Metronidazole Tablets    IVAX Pharmaceuticals,
                          USP, 250 mg and 500 mg.  Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc., 425 Privet
                                                   Rd., Horsham, PA
                                                   19044.
NDA 018969.............  Liposyn III 10%          Hospira, Inc.
                          (soybean oil)
                          Injection, 10%.
NDA 020045.............  Shade UVAGuard           Bayer HealthCare, LLC.
                          (avobenzone,
                          octinoxate,
                          oxybenzone) Lotion, 3%/
                          7.5%/3%.
NDA 020289.............  Gyne-Lotrimin             Do.
                          Combination Pack
                          (clotrimazole) Vaginal
                          Cream and Vaginal
                          Tablets, 1% and 100 mg.

[[Page 7739]]

 
NDA 020421.............  Femstat-3 (butoconazole   Do.
                          nitrate) Vaginal
                          Cream, 2%.
NDA 020499.............  Actron (ketoprofen)       Do.
                          Tablets, 12.5 mg.
NDA 020525.............  Gyne-Lotrimin 3           Do.
                          (clotrimazole) Vaginal
                          Tablets, 200 mg.
NDA 020526.............  Gyne-Lotrimin 3           Do.
                          Combination Pack
                          (clotrimazole) Vaginal
                          Cream and Vaginal
                          Tablets, 1% and 200 mg.
NDA 020574.............  Gyne-Lotrimin 3           Do.
                          (clotrimazole) Vaginal
                          Cream, 2%.
NDA 020619.............  Betoptic Pilo            Alcon Laboratories,
                          (betaxolol HCl;          Inc.
                          pilocarpine HCl)
                          Ophthalmic Suspension,
                          EQ 0.25% base; 1.75%.
NDA 020665.............  Diovan (valsartan)       Novartis
                          Capsules, 80 mg and      Pharmaceuticals Corp.
                          160 mg.
NDA 020807.............  Refludan (lepirudin      Bayer HealthCare
                          recombinant) for         Pharmaceuticals, Inc.
                          Injection, 50 mg/vial.
NDA 020888.............  Lotrimin AF              Bayer HealthCare, LLC.
                          (clotrimazole) Cream,
                          1%.
NDA 020889.............  Lotrimin AF               Do.
                          (clotrimazole) Lotion,
                          1%.
NDA 020890.............  Lotrimin AF               Do.
                          (clotrimazole) Topical
                          Solution, 1%.
NDA 021257.............  Travatan (travoprost)    Alcon Pharmaceuticals,
                          Ophthalmic Solution,     Ltd., 6201 S.
                          0.004%.                  Freeway, TC-45, Fort
                                                   Worth, TX 76134.
NDA 021711.............  Ablavar (gadofosveset    Lantheus Medical
                          trisodium) Injection,    Imaging, Inc., 331
                          2440 mg/10 mL and 3660   Treble Cove Rd.,
                          mg/15 mL.                Building 300-2, North
                                                   Billerica, MA 01862.
NDA 050081.............  Poly-Pred (neomycin      Allergan, Inc., 2525
                          sulfate; polymyxin B     Dupont Dr., P.O. Box
                          sulfate; prednisolone    19534, Irvine, CA
                          acetate) Ophthalmic      92623-9534.
                          Suspension, EQ 0.35%
                          base; 10,000 units/mL;
                          0.5%.
ANDA 061758............  Penicillin V Potassium   Purepac Pharm.,
                          for Oral Solution USP,   Subsidiary of Teva
                          EQ 125 mg base/5 mL      Pharmaceuticals USA,
                          and EQ 250 mg base/5     Inc., 425 Privet Rd.,
                          mL.                      Horsham, PA 19044.
ANDA 061980............  Ampicillin Trihydrate     Do.
                          for Oral Suspension,
                          EQ 125 mg base/5 mL
                          and EQ 250 mg base/5
                          mL.
ANDA 063116............  Tobramycin Sulfate       Hospira, Inc.
                          Injection USP, EQ 40
                          mg base/mL (Pharmacy
                          Bulk Package).
ANDA 065057............  Cefaclor Extended-       World Gen, LLC, 120
                          Release Tablets, EQ      Route 17 North, Suite
                          500 mg base.             127, Paramus, NJ
                                                   07652.
ANDA 071295............  Atropine Injection, EQ   AbbVie, Inc., Dept.
                          2 mg sulfate/0.7 mL.     PA77/Bldg. AP30, 1 N.
                                                   Waukegan Rd., North
                                                   Chicago, IL 60064.
ANDA 071536............  Metoclopramide Tablets   Sun Pharmaceutical
                          USP, EQ 5 mg base and    Industries, Inc., 2
                          EQ 10 mg base.           Independence Way,
                                                   Princeton, NJ 08540.
ANDA 071541............  N.E.E. 1/35 21-day       LPI Holdings, Inc.,
                          (norethindrone and       5000 Plaza on the
                          ethinyl estradiol)       Lake, No. 270,
                          Tablets USP, 1 mg/       Austin, TX 78746.
                          0.035 mg.
ANDA 071542............  N.E.E. 1/35 28-day        Do.
                          (norethindrone and
                          ethinyl estradiol)
                          Tablets USP, 1 mg/
                          0.035 mg.
ANDA 071545............  Norcept-E 1/35 21-day    Janssen
                          (norethindrone and       Pharmaceuticals,
                          ethinyl estradiol)       Inc., 1000 U.S.
                          Tablets USP, 1 mg/       Highway 202, P.O. Box
                          0.035 mg.                300, Raritan, NJ
                                                   08869-0602.
ANDA 071546............  Norcept-E 1/35 28-day     Do.
                          (norethindrone and
                          ethinyl estradiol)
                          Tablets USP, 1 mg/
                          0.035 mg.
ANDA 071690............  Metoprolol Tartrate      Watson Laboratories,
                          Tablets USP, 50 mg.      Inc., Subsidiary of
                                                   Teva Pharmaceuticals
                                                   USA, Inc.
ANDA 071691............  Metoprolol Tartrate       Do.
                          Tablets USP, 100 mg.
ANDA 074633............  Atracurium Besylate      Hospira, Inc.
                          Injection, 10 mg/mL
                          (Single-dose Vials).
ANDA 074639............  Atracurium Besylate       Do.
                          Injection, 10 mg/mL
                          (Abboject Syringe).
ANDA 074929............  Etodolac Capsules USP,   ECI Pharmaceuticals,
                          300 mg.                  LLC, 5311 NW 35th
                                                   Terrace, Fort
                                                   Lauderdale, FL 33309.
ANDA 075870............  Famotidine Injection,    Hospira, Inc.
                          10 mg/mL.
ANDA 076058............  Midazolam HCl Syrup, EQ  Sun Pharmaceutical
                          2 mg base/mL.            Industries, Ltd., c/o
                                                   Sun Pharmaceutical
                                                   Industries, Inc., 2
                                                   Independence Way,
                                                   Princeton, NJ 08540.
ANDA 083140............  Hydrocortisone Tablets,  Nexgen Pharma, Inc.,
                          20 mg.                   46 Corporate Park,
                                                   Suite 200, Irvine, CA
                                                   92606.
ANDA 083633............  Isoniazid Tablets, 300   Sun Pharmaceutical
                          mg.                      Industries, Inc.
ANDA 083634............  Diphenhydramine HCl      Nexgen Pharma, Inc.
                          Capsules, 25 mg.
ANDA 084050............  Isoniazid Tablets, 100    Do.
                          mg.
ANDA 084220............  Meprobamate Tablets,      Do.
                          200 mg.
ANDA 084238............  Pentobarbital Sodium      Do.
                          Tablets, 100 mg.
ANDA 084487............  Phentermine HCl          Upsher-Smith
                          Capsules USP, 30 mg.     Laboratories, LLC,
                                                   301 South Cherokee
                                                   St., Denver, CO
                                                   80223.
ANDA 084589............  Meprobamate Tablets,     Nexgen Pharma, Inc.
                          400 mg.
ANDA 084915............  Folic Acid Tablets, 1     Do.
                          mg.
ANDA 085499............  Potassium Chloride for   Baxter Healthcare
                          Injection Concentrate    Corp., 1620 Waukegan
                          USP, 2                   Rd., McGaw Park, IL
                          milliequivalents/mL.     60085.
ANDA 085985............  Dimenhydrinate Tablets,  Nexgen Pharma, Inc.
                          50 mg.
ANDA 086020............  Phendimetrazine           Do.
                          Tartrate Tablets, 35
                          mg.
ANDA 086187............  Brompheniramine Maleate   Do.
                          Tablets, 4 mg.
ANDA 086392............  Meclizine HCl Tablets,    Do.
                          25 mg (Chewable).
ANDA 086835............  Polaramine               Merck Sharp & Dohme
                          (dexchlorpheniramine     Corp., Subsidiary of
                          maleate) Tablets, 2 mg.  Merck & Co., Inc.
ANDA 086837............  Polaramine                Do.
                          (dexchlorpheniramine
                          maleate) Syrup, 2 mg/5
                          mL.

[[Page 7740]]

 
ANDA 087766............  Thioridazine HCl Oral    Alpharma US Pharms.,
                          Concentrate, 30 mg/mL.   Subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   Inc., 425 Privet Rd.,
                                                   Horsham, PA 19044.
ANDA 087858............  Isoetharine Mesylate      Do.
                          Metered Dose Inhaler,
                          0.34 mg/inhalation.
ANDA 088430............  Phentermine HCl          Upsher-Smith
                          Capsules USP, 30 mg.     Laboratories, LLC.
ANDA 089381............  Hydroxyzine HCl Tablets  Sun Pharmaceutical
                          USP, 10 mg.              Industries, Inc.
ANDA 089382............  Hydroxyzine HCl Tablets   Do.
                          USP, 25 mg.
ANDA 089383............  Hydroxyzine HCl Tablets   Do.
                          USP, 50 mg.
ANDA 089481............  Acetaminophen and        American Therapeutics,
                          Codeine Phosphate        Inc., 89 Carlough
                          Tablets USP, 300 mg/15   Rd., Bohemia, NY
                          mg.                      11716.
ANDA 089482............  Acetaminophen and         Do.
                          Codeine Phosphate
                          Tablets USP, 300 mg/30
                          mg.
ANDA 089489............  Diphenhydramine HCl      Sun Pharmaceutical
                          Capsules, 50 mg.         Industries, Inc.
ANDA 091258............  Furosemide Tablets USP,   Do.
                          20 mg, 40 mg, and 80
                          mg.
NDA 208056.............  Dexilant Solutab         Takeda Pharmaceuticals
                          (dexlansoprazole)        U.S.A., Inc., One
                          Delayed-Release Orally   Takeda Pkwy.,
                          Disintegrating           Deerfield, IL 60015.
                          Tablets, 30 mg.
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    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of March 
26, 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 March 26, 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: February 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03607 Filed 2-21-18; 8:45 am]
 BILLING CODE 4164-01-P