Document ID: FDA-2019-N-5843-0001
Agency: fda
Document Type: Notice
Title: Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19 New
Drug Applications
Posted Date: 2020-01-08T05:00Z

[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 915-916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00075]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5843]

Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19 
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 19 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applications be withdrawn.

DATES: Approval is withdrawn as of February 7, 2020.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

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 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 004570..................  Heparin Sodium        Pharmacia and Upjohn
                               Injection, 1,000      Co. (a subsidiary
                               units/milliliter      of Pfizer Inc.),
                               (mL), 5,000 units/    235 East 42nd St.,
                               mL, and 10,000        New York, NY 10017-
                               units/mL.             7555.
NDA 009838..................  Reserpine Tablets,    Sandoz Inc., 2555 W.
                               0.1 milligram (mg)    Midway Blvd.,
                               and 0.25 mg.          Broomfield, CO
                                                     80020-1632.
NDA 017063..................  Ismotic (isosorbide   Alcon Research, LLC,
                               solution), 100        6201 South Freeway,
                               grams (g)/220 mL.     Fort Worth, TX
                                                     76134-2099.
NDA 017521..................  Dextrose Injection,   Baxter Healthcare
                               0.2 g/mL, 0.3 g/mL,   Corp., 1 Baxter
                               0.4 g/mL, 0.5 g/mL,   Parkway, Deerfield,
                               0.6 g/mL, and 0.7 g/  IL 60015.
                               mL.
NDA 017690..................  Imodium (loperamide   Johnson and Johnson
                               hydrochloride         Consumer Inc.,
                               (HCl)) Capsules, 2    McNeil Consumer
                               mg.                   Healthcare
                                                     Division, 7050 Camp
                                                     Hill Rd., Fort
                                                     Washington, PA
                                                     19034.
NDA 017694..................  Imodium (loperaminde   Do.
                               HCl) Capsules, 2 mg.

[[Page 916]]

 
NDA 018361..................  Serophene             EMD Serono, Inc., 1
                               (clomiphene           Technology Pl.,
                               citrate) Tablets,     Rockland, MA 02370.
                               50 mg.
NDA 020262..................  Taxol (paclitaxel)    HQ Specialty Pharma
                               Injection, 6 mg/mL.   Corp., 120 Route 17
                                                     North, Paramus, NJ
                                                     07652.
NDA 020264..................  Megace (megestrol     Bristol-Myers Squibb
                               acetate) Oral         Co., P.O. Box 4000,
                               Suspension, 40 mg/    Mail Stop: D.2341,
                               mL.                   Princeton, NJ 08543-
                                                     4000.
NDA 020413..................  Zerit (stavudine)      Do.
                               for Oral Solution,
                               1 mg/mL.
NDA 020823..................  Exelon (rivastigmine  Novartis
                               tartrate) Capsules,   Pharmaceuticals
                               equivalent to (EQ)    Corp.
                               1.5 mg base, EQ 3
                               mg base, EQ 4.5 mg
                               base, and EQ 6 mg
                               base.
NDA 021025..................  Exelon (rivastigmine   Do.
                               tartrate) Solution,
                               EQ 2 mg base/mL.
NDA 021217..................  Exalgo                SpecGx LLC, 385
                               (hydromorphone HCl)   Marshall Ave.,
                               Extended-Release      Webster Groves, MO
                               Tablets, 8 mg, 12     63119.
                               mg, 16 mg, and 32
                               mg.
NDA 022046..................  Bupivacaine HCl and   Hospira, Inc., 275
                               epinephrine           North Field Dr.,
                               bitartrate            Bldg. H1, Lake
                               Injection, 0.5%/      Forest, IL 60045.
                               0.0091 mg/mL.
NDA 050632..................  Azactam (aztreonam)   Bristol-Myers Squibb
                               10 mg/mL, 20 mg/mL,   Co.
                               and 40 mg/mL.
NDA 202342..................  Esomeprazole          R2 Pharma, LLC,
                               Strontium Delayed-    11550 North
                               Release Capsules,     Meridian St., Suite
                               EQ 20 mg base and     290, Carmel, IN
                               EQ 40 mg base.        46032-5505.
NDA 207931..................  Technivie             AbbVie Inc., 1 North
                               (ombitasvir,          Waukegan Rd., Dept.
                               paritaprevir, and     PA77/Bldg. AP30,
                               ritonavir) Tablets,   North Chicago, IL
                               12.5 mg/75 mg/50 mg.  60064.
NDA 208603..................  Arymo ER (morphine    Zyla Life Sciences
                               sulfate) Extended-    US Inc., 600 Lee
                               Release Tablets, 15   Rd., Suite 100,
                               mg, 30 mg, and 60     Wayne, PA 19087.
                               mg.
NDA 208624..................  Viekira XR            AbbVie Inc.
                               (dasabuvir,
                               ombitasvir,
                               paritaprevir, and
                               ritonavir) Extended-
                               Release Tablets,
                               200 mg/8.33 mg/50
                               mg/33.33 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
February 7, 2020. Approval of each entire application is withdrawn, 
including any strengths and dosage forms inadvertently missing from the 
table. 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 February 7, 2020 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: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00075 Filed 1-7-20; 8:45 am]
 BILLING CODE 4164-01-P