Document ID: FDA-2021-N-1145-0001
Agency: fda
Document Type: Notice
Title: Aurolife Pharma LLC, et al.; Withdrawal of Approval of Five Abbreviated New Drug Applications
Posted Date: 2021-12-02T05:00Z

[Federal Register Volume 86, Number 229 (Thursday, December 2, 2021)]
[Notices]
[Pages 68502-68503]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26170]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1145]

Aurolife Pharma LLC, et al.; Withdrawal of Approval of Five 
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 five 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of January 3, 2022.

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 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 072514............  Clorazepate Dipotassium  Aurolife Pharma LLC,
                          Tablets, 3.75            2400 U.S. Hwy. 130 N,
                          milligrams (mg), 7.5     Dayton, NJ 08810.
                          mg, and 15 mg.
ANDA 077840............  Ondansetron              Hospira, Inc., 275 N
                          Hydrochloride            Field Dr., Bldg. H1,
                          Injection, Equivalent    Lake Forest, IL
                          to (EQ) 2 mg base/       60045.
                          milliliters (mL).
ANDA 077988............  Fluconazole in Dextrose  Woodward Pharma
                          5% Injection, 200 mg/    Services LLC, 47220
                          100 mL (2 mg/mL) and     Cartier Dr., Wixom,
                          400 mg/200 mL (2 mg/     MI 48393.
                          mL).

[[Page 68503]]

 
ANDA 203265............  Lidocaine Patch, 5%....  Noven Pharmaceuticals,
                                                   Inc., 11960 SW 144th
                                                   St., Miami, FL 33186.
ANDA 203967............  Escitalopram Oxalate     Antrim Pharmaceuticals
                          Solution, EQ 5 mg base/  LLC, 655 W Northcroft
                          5 mL.                    Ct., Lake Forest, IL
                                                   60045.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
January 3, 2022. 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 January 3, 2022 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 23, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-26170 Filed 12-1-21; 8:45 am]
BILLING CODE 4164-01-P