[Federal Register Volume 82, Number 190 (Tuesday, October 3, 2017)]
[Notices]
[Pages 46079-46081]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21177]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-4563]


Johnson & Johnson Consumer Inc. et al.; Withdrawal of Approval of 
7 New Drug Applications and 71 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 7 new drug applications (NDAs) and 71 abbreviated new drug 
applications (ANDAs) from multiple

[[Page 46080]]

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that the approval of the applications be withdrawn.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: Withdrawal of approval is effective November 2, 2017.

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 pursuant to 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.

----------------------------------------------------------------------------------------------------------------
             Application No.                            Drug                              Applicant
----------------------------------------------------------------------------------------------------------------
NDA 014349..............................  Delfen (nonoxynol-9)              Johnson & Johnson Consumer Inc., 199
                                           Contraceptive Foam, 12.5%.        Grandview Rd., Skillman, NJ 08558.
ANDA 019346.............................  Dextrose 60% Injection USP in     Hospira, Inc., 275 North Field Dr.,
                                           Plastic Container.                Dept. 389, Bldg. H2-2, Lake Forest,
                                                                             IL 60045.
NDA 019810..............................  Prilosec (omeprazole) Delayed-    AstraZeneca Pharmaceuticals LP, One
                                           Release Capsules, 10 milligrams   MedImmune Way, Gaithersburg, MD
                                           (mg), 20 mg, and 40 mg.           20878.
NDA 020184..............................  Aceon (perindopril erbumine)      Symplmed Pharmaceuticals, LLC, 5375
                                           Tablets, 2 mg, 4 mg, and 8 mg.    Medspace Way, Cincinnati, OH 45227.
NDA 022345..............................  Potiga (ezogabine) Tablets, 50    GlaxoSmithKline Intellectual
                                           mg, 200 mg, 300 mg, and 400 mg.   Property Management LTD England, c/
                                                                             o GlaxoSmithKline, 1250 South
                                                                             Collegeville Road, P.O. Box 5089,
                                                                             Collegeville, PA 19426.
NDA 021712..............................  Fluxid (famotidine) Orally        UCB, Inc., 1950 Lake Park Dr., Bldg.
                                           Disintegrating Tablets, 20 mg     2100, Smyrna, GA 30080.
                                           and 40 mg.
ANDA 040108.............................  Acetazolamide for Injection USP,  Hospira, Inc.
                                           Equivalent to (EQ) 500 mg base/
                                           vial.
ANDA 040206.............................  Digoxin Injection USP, 0.25 mg/    Do.
                                           milliliter (mL).
ANDA 040527.............................  Phentermine Hydrochloride (HCl)   Sun Pharmaceutical Industries, Inc.,
                                           Capsules USP, 37.5 mg.            270 Prospect Plains Rd., Cranbury,
                                                                             NJ 08512.
ANDA 040899.............................  Hydroxyzine HCl Tablets USP, 10    Do.
                                           mg, 25 mg, and 50 mg.
ANDA 060099.............................  Penicillin G Procaine for         Pfizer Inc., 235 East 42nd St., New
                                           Injection, 300,000 units/vial     York, NY 10017.
                                           and 1,500,000 units/vial.
ANDA 063161.............................  Tobramycin Injection USP, EQ 40   Hospira, Inc.
                                           mg base/mL.
ANDA 070171.............................  Naloxone HCl Injection USP, 0.02   Do.
                                           mg/mL.
ANDA 070186.............................  Disopyramide Phosphate Capsules   Ivax Pharmaceuticals, Inc.,
                                           USP, EQ 100 mg base.              Subsidiary of Teva Pharmaceuticals
                                                                             USA, Inc., 425 Privet Rd., Horsham,
                                                                             PA 19044.
ANDA 070233.............................  Propranolol HCl Tablets USP, 20   Teva Pharmaceuticals USA, Inc., 425
                                           mg.                               Privet Rd., Horsham, PA 19044.
ANDA 070255.............................  Naloxone HCl Injection, 0.4 mg/   Hospira, Inc.
                                           mL.
ANDA 070698.............................  Methyldopate HCl Injection USP,    Do.
                                           50 mg/mL, ADD-Vantage Vial.
ANDA 070699.............................  Methyldopate HCl Injection USP,    Do.
                                           50 mg/mL, Fliptop Vial.
ANDA 070739.............................  Verapamil HCl Injection, 2.5 mg/   Do.
                                           mL, 2 mL Abbojet-PA Syringe.
ANDA 070740.............................  Verapamil HCl Injection, 2.5 mg/   Do.
                                           mL, 4 mL Abbojet Syringe Vial.
ANDA 070803.............................  Enflurane USP, 99.9%............  Abbott Laboratories, Hospital
                                                                             Products Division, 200 Abbott Park
                                                                             Rd., D389, Bldg. J45-2, Abbott
                                                                             Park, IL 60064.
ANDA 070888.............................  Aminocaproic Acid Injection USP,  Hospira, Inc.
                                           250 mg/mL.
ANDA 071357.............................  Tolazamide Tablets USP, 100 mg..  Sun Pharmaceutical Industries, Inc.
ANDA 071438.............................  Ritodrine HCl in Dextrose 5%      Hospira, Inc.
                                           Injection, 30 mg/100 mL.
ANDA 071618.............................  Ritodrine HCl Injection USP, 10    Do.
                                           mg/mL.
ANDA 071619.............................  Ritodrine HCl Injection USP, 15    Do.
                                           mg/mL.
ANDA 071982.............................  Droperidol and Fentanyl Citrate    Do.
                                           Injection, 2.5 mg/mL and EQ
                                           0.05 mg base/mL.
ANDA 072321.............................  Pancuronium Bromide Injection, 2   Do.
                                           mg/mL.
ANDA 073199.............................  Sulfamethoxazole and               Do.
                                           Trimethoprim Injection USP, 80
                                           mg/mL and 16 mg/mL.
ANDA 073310.............................  Tolmetin Sodium Tablets USP, EQ   Sun Pharmaceutical Industries, Inc.
                                           200 mg base.
ANDA 073428.............................  CO-LAV (polyethylene glycol 3350  Vintage Pharmaceuticals, 150 Vintage
                                           and electrolytes) for Oral        Dr., Huntsville, AL 35811.
                                           Suspension.
ANDA 073433.............................  GO-EVAC (polyethylene glycol       Do.
                                           3350 and electrolytes) for Oral
                                           Suspension.
ANDA 073677.............................  Carbastat (carbachol)             Novartis Pharmaceuticals Corp., One
                                           Intraocular Solution, 0.01%.      Health Plaza, East Hanover, NJ
                                                                             07936.
ANDA 074168.............................  Diltiazem HCl Tablets USP, 30     Ivax Pharmaceuticals, Inc.,
                                           mg, 60 mg, 90 mg, and 120 mg.     Subsidiary of Teva Pharmaceuticals
                                                                             USA, Inc.
ANDA 074280.............................  Lorazepam Injection USP, 2 mg/mL  Hospira, Inc.
                                           and 4 mg/mL.
ANDA 074296.............................  Cimetidine HCl Injection, EQ 300   Do.
                                           mg base/2 mL (Carpuject).
ANDA 074412.............................  Cimetidine HCl Injection, EQ 300   Do.
                                           mg base/2 mL.
ANDA 074422.............................  Cimetidine HCl Injection, EQ 300   Do.
                                           mg base/2 mL, ADD-Vantage Vial.
ANDA 074468.............................  Cimetidine HCl in Sodium           Do.
                                           Chloride 0.9% Injection in
                                           Plastic Container, EQ 90 mg
                                           base/100 mL, EQ 120 mg base/100
                                           mL, EQ 180 mg base/100 mL, EQ
                                           240 mg base/100 mL, EQ 360 mg/
                                           100 mL, and EQ 480 mg base/100
                                           mL.
ANDA 074620.............................  Butorphanol Tartrate Injection     Do.
                                           USP, 1 mg/mL and 2 mg/mL.
ANDA 074758.............................  Acyclovir for Injection USP, EQ    Do.
                                           500 mg base/vial and EQ 1 gram
                                           (g) base/vial.

[[Page 46081]]

 
ANDA 074801.............................  Ketorolac Tromethamine Injection   Do.
                                           USP, 15 mg/mL and 30 mg/mL.
ANDA 075385.............................  Buspirone HCl Tablets USP, 5 mg,  Ivax Pharmaceuticals, Inc.,
                                           10 mg, and 15 mg.                 Subsidiary of Teva Pharmaceuticals
                                                                             USA, Inc.
ANDA 075453.............................  Doxazosin Tablets USP, EQ 1 mg     Do.
                                           base, EQ 2 mg base, EQ 4 mg
                                           base, and EQ 8 mg base.
ANDA 076883.............................  Sotalol HCl Tablets USP, 80 mg,   Teva Pharmaceuticals USA, Inc.
                                           120 mg, and 160 mg.
ANDA 077052.............................  Citalopram Hydrobromide Tablets,  Sun Pharmaceutical Industries, Inc.
                                           EQ 10 mg base, EQ 20 mg base,
                                           and EQ 40 mg base.
ANDA 077937.............................  Meloxicam Tablets, 7.5 mg and 15   Do.
                                           mg.
ANDA 078081.............................  Amlodipine Besylate Tablets, EQ    Do.
                                           2.5 mg base, EQ 5 mg base, and
                                           EQ 10 mg base.
ANDA 078158.............................  Fosphenytoin Sodium Injection     Hospira, Inc.
                                           USP, EQ 50 mg Phenytoin Soudium/
                                           mL.
ANDA 078483.............................  Zolpidem Tartrate Extended-       Synthon Pharmaceuticals, Inc., 1007
                                           Release Tablets USP, 6.25 mg      Slater Rd., Suite 150, Durham, NC
                                           and 12.5 mg.                      27703.
ANDA 080136.............................  Isoniazid Tablets, 100 mg.......  Sun Pharmaceutical Industries, Inc.
ANDA 080209.............................  Prednisone Tablets USP, 5 mg....  Contract Pharmacal Corp., c/o
                                                                             SciRegs International Inc., 6333
                                                                             Summercrest Dr., Columbia, MD
                                                                             21045.
ANDA 080224.............................  Sorbitol; Mannitol Irrigation     Hospira, Inc.
                                           Solution, 2.7 g/100 mL; 540 mg/
                                           100 mL.
ANDA 083345.............................  Potassium Chloride for Injection   Do.
                                           Concentrate USP, 1
                                           milliequivalent (mEQ)/mL, 1.5
                                           mEQ/mL, and 2 mEQ/mL.
ANDA 083808.............................  Quinidine Sulfate Tablets USP,    Contract Pharmacal Corp., c/o
                                           200 mg.                           SciRegs International Inc.
ANDA 084623.............................  Chlordiazepoxide HCl Capsules     Upsher-Smith Laboratories, Inc.,
                                           USP, 10 mg.                       6701 Evenstad Dr., Maple Grove, MN
                                                                             55369.
ANDA 084644.............................  Chlordiazepoxide HCl Capsules      Do.
                                           USP, 5 mg.
ANDA 084710.............................  Ogen (estropipate) Vaginal Cream  Pfizer Inc.
                                           USP, 1.5 mg/g.
ANDA 085061.............................  Folic Acid Tablets USP, 1 mg....  Contract Pharmacal Corp., c/o
                                                                             SciRegs International Inc.
ANDA 085933.............................  Phentermine HCl Tablets USP.....  Lemmon Co., 650 Cathill Rd.,
                                                                             Sellersville, PA 18960.
ANDA 086494.............................  Chlordiazepoxide HCl Capsules,    Teva Pharmaceuticals USA, Inc.
                                           25 mg.
ANDA 086821.............................  Hydroxyzine HCl Injection USP,    Hospira, Inc.
                                           50 mg/mL.
ANDA 087416.............................  Hydroxyzine HCl Injection USP,     Do.
                                           25 mg/mL, Carpuject.
ANDA 087546.............................  Hydroxyzine HCl Injection USP,     Do.
                                           50 mg/mL, Carpuject.
ANDA 087862.............................  Hydroxyzine HCl Tablets USP, 100  Sun Pharmaceutical Industries, Inc.
                                           mg.
ANDA 088147.............................  Aminophylline in Sodium Chloride  Hospira, Inc.
                                           0.45% Injection, 100 mg/100 mL
                                           and 200 mg/100 mL.
ANDA 088367.............................  Lidocaine HCl Injection USP, 10%   Do.
ANDA 088542.............................  Lidocaine HCl Injection USP, 4%.   Do.
ANDA 089162.............................  Cyclopentolate HCl Ophthalmic     Alcon Pharmaceuticals, Ltd., 6201
                                           Solution, 1%.                     South Freeway TC-45, Fort Worth, TX
                                                                             76134.
ANDA 089347.............................  Diatrizoate Meglumine and         Bracco Diagnostics Inc., 259
                                           Diatrizoate Sodium Injection      Prospect Plains Rd., Bldg. H,
                                           USP, 66%; 10%.                    Monroe Township, NJ 08831.
ANDA 089393.............................  Glycopyrrolate Injection USP,     Hospira, Inc.
                                           0.2 mg/mL.
ANDA 089488.............................  Diphenhydramine HCl Capsules, 25  Sun Pharmaceutical Industries, Inc.
                                           mg.
ANDA 089521.............................  Phenytoin Sodium Injection USP,   Hospira, Inc.
                                           50 mg/mL, Ampule.
ANDA 089537.............................  Procainamide HCl Injection USP,    Do.
                                           500 mg/mL, Carpuject.
ANDA 089744.............................  Phenytoin Sodium Injection USP,    Do.
                                           50 mg/mL, Carpuject.
ANDA 089915.............................  Leucovorin Calcium for            Pharmachemie B.V., c/o SICOR
                                           Injection, EQ 100 mg base/vial.   Pharmaceuticals, Inc., 19 Hughes,
                                                                             Irvine, CA 92618.
NDA 202258..............................  Victrelis (boceprevir) Capsules,  Merck Sharp & Dohme Corp.,
                                           200 mg.                           Subsidiary of Merck & Company,
                                                                             Inc., 1 Merck Dr., P.O. Box 100,
                                                                             Whitehouse Station, NJ 08889.
NDA 203093..............................  Vitekta (elvitegravir) Tablets,   Gilead Sciences, Inc., 333 Lakeside
                                           85 mg and 150 mg.                 Dr., Foster City, CA 94404.
----------------------------------------------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn, effective 
November 2, 2017. 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 the date that this notice becomes 
effective (see 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: September 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-21177 Filed 10-2-17; 8:45 am]
BILLING CODE 4164-01-P