Document ID: FDA-2019-N-5608-0001
Agency: fda
Document Type: Notice
Title: Wockhardt Limited, et al.; Withdrawal of Approval of 28 Abbreviated New Drug Applications
Posted Date: 2020-02-14T05:00Z

[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Notices]
[Pages 8598-8599]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03025]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-5608]

Wockhardt Limited, et al.; Withdrawal of Approval of 28 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of 28 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of March 16, 2020.

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 040732.................  Phenytoin Sodium      Wockhardt Limited, c/
                               Capsules, 100         o Morton Grove
                               milligrams (mg)       Pharmaceuticals,
                               (Extended).           Inc., 6451 Main
                                                     St., Morton Grove,
                                                     IL 60053.
ANDA 065230.................  Ceftriaxone for       Hospira, Inc., 275
                               Injection,            North Field Dr.,
                               Equivalent to (EQ)    Bldg. H1, Lake
                               250 mg base/vial;     Forest, IL 60045.
                               EQ 500 mg base/
                               vial; EQ 1 gram (g)
                               base/vial; EQ 2 g
                               base/vial.
ANDA 065231.................  Ceftriaxone for       Do.
                               Injection, EQ 1 g
                               base/vial; EQ 2 g
                               base/vial Piggy
                               Back.
ANDA 065290.................  Cefotaxime Sodium     Do.
                               for Injection, EQ
                               500 mg base/vial;
                               EQ 1 g base/vial;
                               EQ 2 g base/vial.
ANDA 065292.................  Cefotaxime Sodium     Do.
                               for Injection, EQ
                               10 g base/vial
                               Pharmacy Bulk
                               Package.
ANDA 065293.................  Cefotaxime Sodium     Do.
                               for Injection, EQ 1
                               g base/vial; EQ 2 g
                               base/vial.
ANDA 065312.................  Cefoxitin for         Do.
                               Injection, EQ 10 g
                               base/vial Pharmacy
                               Bulk Package.
ANDA 065313.................  Cefoxitin for         Do.
                               Injection, EQ 1 g
                               base/vial; EQ 2 g
                               base/vial.
ANDA 065369.................  Cefepime              Do.
                               Hydrochloride (HCl)
                               for Injection, EQ
                               500 mg base/vial;
                               EQ 1 g base/vial;
                               EQ 2 g base/vial.
ANDA 065483.................  Cefuroxime Sodium     Do.
                               for Injection, EQ
                               750 mg base/vial;
                               EQ 1.5 g base/vial.

[[Page 8599]]

 
ANDA 065484.................  Cefuroxime Sodium     Do.
                               for Injection, EQ
                               7.5 g base/vial
                               Pharmacy Bulk
                               Package.
ANDA 065503.................  Cefuroxime Sodium     Do.
                               for Injection, EQ
                               1.5 g base/vial.
ANDA 075250.................  Prednisolone Sodium   Bausch Health US,
                               Phosphate Oral        LLC, 400 Somerset
                               Solution, EQ 15 mg    Corporate Blvd.,
                               base/5 milliliters    Bridgewater, NJ
                               (mL).                 08807.
ANDA 075618.................  Acetaminophen,        Hikma
                               Butalbital,           Pharmaceuticals USA
                               Caffeine, and         Inc., 1809 Wilson
                               Codeine Phosphate     Rd., Columbus, OH
                               Capsules, 325 mg,     43228.
                               50 mg, 40 mg, and
                               30 mg.
ANDA 090375.................  Ampicillin and        Hospira, Inc.
                               Sulbactam for
                               Injection, EQ 1 g
                               base/vial and EQ
                               500 mg base/vial;
                               EQ 2 g base/vial
                               and EQ 1 g base/
                               vial.
ANDA 090646.................  Ampicillin and        Do.
                               Sulbactam for
                               Injection, EQ 10 g
                               base/vial and EQ 5
                               g base/vial.
ANDA 090653.................  Ampicillin and        Do.
                               Sulbactam for
                               Injection, EQ 1 g
                               base/vial and EQ
                               500 mg base/vial;
                               EQ 2 g base/vial
                               and EQ 1 g base/
                               vial.
ANDA 090825.................  Imipenem and          Do.
                               Cilastatin for
                               Injection, EQ 250
                               mg base/vial and
                               250 mg base/vial;
                               EQ 500 mg base/vial
                               and 500 mg/vial.
ANDA 090940.................  Meropenem for         Do.
                               Injection, 500 mg/
                               vial, and 1 g/vial.
ANDA 091007.................  Imipenem and          Do.
                               Cilastatin for
                               Injection, EQ 500
                               mg base/vial and
                               500 mg/vial.
ANDA 202268.................  Cefepime HCl for      Do.
                               Injection, EQ 1 g
                               base/vial; EQ 2 g
                               base/vial.
ANDA 202563.................  Ceftriaxone for       Do.
                               Injection, EQ 1 g
                               base/vial; EQ 2 g
                               base/vial.
ANDA 202864.................  Ampicillin Sodium     Do.
                               for Injection, EQ
                               250 mg base/vial;
                               EQ 500 mg base/
                               vial; EQ 1 g base/
                               vial; EQ 2 g base/
                               vial.
ANDA 202865.................  Ampicillin Sodium     Do.
                               for Injection, EQ
                               10 g base/vial
                               Pharmacy Bulk
                               Package.
ANDA 203132.................  Cefotaxime Sodium     Do.
                               for Injection, EQ 1
                               g base/vial; EQ 2 g
                               base/vial.
ANDA 204879.................  Pyridoxine HCl        Mylan Institutional,
                               Injection, 100 mg/    LLC, 4901 Hiawatha
                               mL.                   Dr., Rockford, IL
                                                     61103.
ANDA 206062.................  Doxorubicin HCl for   Hisun Pharmaceutical
                               Injection, USP, 20    Hangzhou Co., LTD,
                               mg/vial.              200 Crossing Blvd.,
                                                     2nd Floor,
                                                     Bridgewater, NJ
                                                     08807.
ANDA 206195.................  Daunorubicin HCl for  Do.
                               Injection, EQ 20 mg
                               base/vial.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of March 
16, 2020. 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 March 16, 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: February 11, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03025 Filed 2-13-20; 8:45 am]
 BILLING CODE 4164-01-P