Document ID: FDA-2023-N-5431-0001
Agency: fda
Document Type: Notice
Title: Hospira, Inc., et al.; Withdrawal of Approval of Eight Abbreviated New Drug Applications
Posted Date: 2023-12-19T05:00Z

[Federal Register Volume 88, Number 242 (Tuesday, December 19, 2023)]
[Notices]
[Page 87787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27853]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-N-5431]

Hospira, Inc., et al.; Withdrawal of Approval of Eight 
Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of January 18, 2024.

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, [email protected].

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 the 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 063081.............  Tobramycin Sulfate,     Hospira, Inc., 275
                           Injectable,             North Field Dr.,
                           Equivalent to (EQ)      Building H1-3S, Lake
                           1.2 milligrams (mg)     Forest, IL 60045.
                           base/milliliters
                           (mL), EQ 1.6 mg base/
                           mL, EQ 80 mg base/100
                           mL.
ANDA 063112.............  Tobramycin Sulfate,     Do.
                           Injection, EQ 10 mg
                           base/mL.
ANDA 078907.............  Fentanyl Citrate,       SpecGx LLC, 385
                           Troche/Lozenges, EQ     Marshall Ave.,
                           0.2 mg base, EQ 0.4     Webster Groves, MO
                           mg base, EQ 0.6 mg      63119.
                           base, EQ 0.8 mg base,
                           EQ 1.2 mg base, EQ
                           1.6 mg base.
ANDA 080629.............  Promethazine            Watson Laboratories,
                           Hydrochloride (HCl),    Inc. (an indirect,
                           Injectable, 50 mg/mL.   wholly owned
                                                   subsidiary of Teva
                                                   Pharmaceuticals USA,
                                                   Inc.), 400 Interpace
                                                   Parkway, Building A,
                                                   Parsippany, NJ 07054.
ANDA 091170.............  Zoledronic Acid,        Breckenridge
                           Injectable, EQ 4 mg     Pharmaceutical, Inc.,
                           base/5 mL.              15 Massirio Dr.,
                                                   Suite 201, Berlin, CT
                                                   06037.
ANDA 201846.............  Azelastine HCl,         Apotex Corp, U.S.
                           Metered Spray, 0.2055   Agent for Apotex
                           mg/spray.               Inc., 2400 North
                                                   Commerce Parkway,
                                                   Suite 400, Weston, FL
                                                   33326.
ANDA 207698.............  Nevirapine Extended-    Aurobindo Pharma USA,
                           Release Tablets, 400    Inc., U.S. Agent for
                           mg.                     Aurobindo Pharma
                                                   Limited, 279
                                                   Princeton-Hightstown
                                                   Rd., East Windsor, NJ
                                                   08520.
ANDA 208616.............  Nevirapine Extended-    Do.
                           Release Tablets, 100
                           mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
January 18, 2024. 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 listed in the table without an approved new drug 
application or ANDA violates sections 505(a) and 301(d) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355(a) and 331(d)). Drug 
products that are listed in the table that are in inventory on January 
18, 2024 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: December 14, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27853 Filed 12-18-23; 8:45 am]
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