Parke-Davis, Subsidiary of Pfizer, Inc. et al.; Withdraw of Approval of 38 New Drug Applications and 43 Abbreviated New Drug Applications

 
CONTENT

Federal Register, Volume 83 Issue 36 (Thursday, February 22, 2018)

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in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of March 26, 2018.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

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Application No. Drug Applicant

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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