Document ID: FDA-2018-N-3761-0001
Agency: fda
Document Type: Notice
Title: Sanofi-Aventis, U.S., LLC, et al.; Withdrawal of Approval of 20 New Drug Applications
Posted Date: 2018-10-19T04:00Z

[Federal Register Volume 83, Number 203 (Friday, October 19, 2018)]
[Notices]
[Pages 53068-53069]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22805]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3761]

Sanofi-Aventis, U.S., LLC, et al.; Withdrawal of Approval of 20 
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 20 new drug applications (NDAs) from multiple 
applicants. The applicants 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applications be withdrawn.

DATES: Approval is withdrawn as of November 19, 2018.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 applicants 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 described 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.

[[Page 53069]]

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         Application No.                          Drug                                 Applicant
----------------------------------------------------------------------------------------------------------------
NDA 006002.......................  Aralen Hydrochloride (chloroquine  Sanofi-Aventis, U.S., LLC, 55 Corporate
                                    hydrochloride (HCl)) Injection,    Dr., Bridgewater, NJ 08807.
                                    Equivalent to (EQ) 40 milligram
                                    (mg) base/milliliter (mL);
                                    Aralen (chloroquine phosphate)
                                    Tablets, EQ 300 mg base.
NDA 008107.......................  Leucovorin calcium for Injection   Hospira Inc., Subsidiary of Pfizer Inc.,
                                    USP, EQ 60 mg base/vial for        235 East 42nd St., New York, NY 10017.
                                    solution, oral; EQ 3 mg base/mL
                                    injection; EQ 50 mg base/vial
                                    injection; EQ 100 mg base/vial
                                    injection; EQ 350 mg base/vial
                                    injection.
NDA 009321.......................  Cholografin Meglumine (iodipamide  Bracco Diagnostics, Inc., 259 Prospect
                                    meglumine) Injection, 10.3% and    Plains Rd., Monroe Township, NJ 08831.
                                    52% (cholografin sodium, 20%).
NDA 017566.......................  Brevicon (ethinyl estradiol;       Allergan Pharmaceuticals International,
                                    norethindrone) Tablets, 0.035 mg/  Ltd., c/o Allergan Sales, LLC, 2525
                                    0.5 mg (21-Day Regimen).           Dupont Dr., Irvine, CA 92612.
NDA 018181.......................  Mycelex (clotrimazole) Topical     Bayer HealthCare LLC, 100 Bayer Blvd., 100
                                    Solution, 1%.                      Bayer Rd., Pittsburgh, PA 15205.
NDA 018182.......................  Mycelex-7 (clotrimazole) Tablets,  Do.
                                    100 mg.
NDA 018183.......................  Mycelex (clotrimazole) Topical     Do.
                                    Cream, 1%.
NDA 018230.......................  Mycelex-7 (clotrimazole) Topical   Do.
                                    Vaginal Cream, 1%.
NDA 018856.......................  D-Xylose (xylose) Powder, 25       Lyne Laboratories, 10 Burke Dr., Brockton,
                                    grams (g)/bottle.                  MA 02301.
NDA 018874.......................  Calcijex (calcitriol) Injection,   AbbVie, Inc., 1 North Waukegan Rd., North
                                    0.001 mg/mL and 0.002 mg/mL.       Chicago, IL 60064.
NDA 020214.......................  Zemuron (rocronium bromide)        Organon USA Inc., Subsidiary of Merck &
                                    Injection, 50 mg/5 mL (10 mg/      Co., Inc., 2000 Galloping Hill Rd.,
                                    mL); 10 mg/mL (10 mg/mL); 100 mg/  Kenilworth, NJ 07033.
                                    10 mL (10 mg/mL).
NDA 020389.......................  Mycelex-7 Combination Pack         Bayer HealthCare LLC.
                                    (clotrimazole) Topical Vaginal
                                    Cream and Tablets, 1%, 100 mg.
NDA 020528.......................  Mavik (trandolapril) Tablets, 1    AbbVie, Inc.
                                    mg, 2 mg, and 4 mg.
NDA 020738.......................  Teveten (eprosartan mesylate)      Do.
                                    Tablets, 300 mg, 400 mg, and 600
                                    mg.
NDA 020863.......................  Pletal (cilostazol) Tablets, 50    Otsuka Pharmaceutical Development and
                                    mg and 100 mg.                     Commercialization, Subsidiary of Otsuka
                                                                       Pharmaceutical Company, Ltd., 2440
                                                                       Research Blvd., Rockville, MD 20850.
NDA 021268.......................  Teveten HCT (eprosartan mesylate   AbbVie, Inc.
                                    and hydrochlorothiazide)
                                    Tablets, 600/12.5 mg and 600/25
                                    mg.
NDA 021410.......................  Avandamet (rosiglitazone maleate   GlaxoSmithKline, 1250 South Collegeville
                                    and metformin hydrochloride        Rd., Collegeville, PA 19426.
                                    (HCl)) Tablets, 500 mg EQ 1 mg
                                    base; 500 mg EQ 2 mg base; 500
                                    mg EQ 4 mg base; 1 g EQ 2 mg
                                    base; 1 g EQ 4 mg base.
NDA 021511.......................  Copegus (ribavirin) Tablets, 200   Hoffmann La-Roche, Inc., Subsidiary of
                                    mg and 400 mg.                     Genentech, Inc., 1 DNA Way, South San
                                                                       Francisco, CA 94080.
NDA 021700.......................  Avandaryl (glimepiride and         SB Pharmco Puerto Rico Inc., Subsidiary of
                                    rosiglitazone maleate) Tablets,    GlaxoSmithKline, 1250 South Collegeville
                                    1 mg/4 mg; 2 mg/4 mg; 2 mg/8 mg;   Rd., Collegeville, PA 19426.
                                    4 mg/4 mg; 4 mg/8 mg.
NDA 205123.......................  Olysio (simeprevir sodium)         Janssen Pharmaceuticals, Inc., 1000 U.S.
                                    Capsules, EQ 150 mg base.          Rte. 202 South, Raritan, NJ 08869.
----------------------------------------------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
November 19, 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 November 19, 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: October 15, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22805 Filed 10-18-18; 8:45 am]
 BILLING CODE 4164-01-P