Document ID: FDA-2019-N-0163-0003
Agency: fda
Document Type: Notice
Title: Hospira, Inc., et al.; Withdrawal of Approval of Six Abbreviated New Drug Applications
Posted Date: 2019-11-29T05:00Z

[Federal Register Volume 84, Number 230 (Friday, November 29, 2019)]
[Notices]
[Pages 65821-65822]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-25901]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0163]

Hospira, Inc., et al.; Withdrawal of Approval of Six 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 six abbreviated new drug applications (ANDAs) 
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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of December 30, 2019.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980, Martha.Nguyen@fda.hhs.gov.

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.

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 040806.................  Mepivacaine           Hospira, Inc., 275
                               Hydrochloride (HCl)   North Field Dr.,
                               Injection USP, 3%,    Bldg. H, Lake
                               30 milligrams (mg)/   Forest, IL 60045.
                               milliliter (mL).

[[Page 65822]]

 
ANDA 077523.................  Fluconazole for Oral  IVAX
                               Suspension, 50 mg/5   Pharmaceuticals,
                               mL and 200 mg/5 mL.   Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 078772.................  Epinephrine and       Hospira, Inc.
                               Lidocaine HCl, 0.01
                               mg/mL; 2% and 0.02
                               mg/mL; 2%.
ANDA 079138.................  Articaine HCl and     Do.
                               Epinephrine
                               Bitartrate
                               Injection, 4%; EQ
                               0.017 mg base/1.7
                               mL, 4%; EQ 0.01 mg
                               base/mL.
ANDA 204236.................  Norethindrone         Aurobindo Pharma
                               Acetate Tablets, 5    Ltd., 279 Princeton-
                               mg.                   Hightstown Rd.,
                                                     East Windsor, NJ
                                                     08520.
ANDA 204421.................  Tramadol HCl          Do.
                               Extended-Release
                               Tablets, 100 mg,
                               200 mg, and 300 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
December 30, 2019. Approval of each entire application is withdrawn, 
including any strengths or products 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 December 30, 2019 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: November 25, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-25901 Filed 11-27-19; 8:45 am]
 BILLING CODE 4164-01-P