Document ID: FDA-2022-N-0413-0001
Agency: fda
Document Type: Notice
Title: Baxter Healthcare Corporation, et al.; Withdrawal of Approval of 14 Abbreviated New Drug Applications
Posted Date: 2022-04-25T04:00Z

[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24320-24321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-08744]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0413]

Baxter Healthcare Corporation, et al.; Withdrawal of Approval of 
14 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, Health and Human Service (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is 
withdrawing approval of 14 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of May 25, 2022.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.

[[Page 24321]]

------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 075695.................  Butorphanol Tartrate  Baxter Healthcare
                               Injection, 1          Corporation, One
                               milligram (mg)/       Baxter Pkwy.,
                               milliliter (mL),      Deerfield, IL
                               and 2 mg/mL.          60015.
ANDA 075697.................  Butorphanol Tartrate   Do.
                               Injection, 2 mg/mL.
ANDA 077290.................  Oxycodone             Nesher
                               Hydrochloride (HCl)   Pharmaceuticals
                               Tablets, 5 mg, 10     (USA) LLC, 13910
                               mg, 15 mg, 20 mg,     St. Charles Rock
                               30 mg.                Rd., Bridgeton, MO
                                                     63044.
ANDA 078564.................  Granisetron HCl       Morton Grove
                               Injection,            Pharmaceuticals
                               Equivalent to (EQ)    Inc., 6451 Main
                               1 mg base/mL (EQ 1    St., Morton Grove,
                               mg base/mL).          IL 60053.
ANDA 078565.................  Granisetron HCl        Do.
                               Injection, EQ 4 mg
                               base/4 mL (EQ 1 mg
                               base/mL).
ANDA 078566.................  Granisetron HCl        Do.
                               Injection, EQ 0.1
                               mg base/mL (EQ 0.1
                               mg base/mL).
ANDA 088342.................  Fluoxymesterone       Upsher-Smith
                               Tablets, 10 mg.       Laboratories, LLC,
                                                     6701 Evenstad Dr.,
                                                     Maple Grove, MN
                                                     55369.
ANDA 202032.................  Lamivudine Tablets,   Aurobindo Pharma
                               150 mg and 300 mg.    USA, Inc., 279
                                                     Princeton-
                                                     Hightstown Rd.,
                                                     East Windsor, NJ
                                                     08520.
ANDA 205322.................  Efavirenz Tablets,     Do.
                               600 mg.
ANDA 205690.................  Choline C-11          University of Texas
                               Injection, 4-100      MD Anderson Cancer
                               millicurie/mL.        Center, 1881 East
                                                     Rd., Unit 1903,
                                                     Houston, TX 77054.
ANDA 207653.................  Rosuvastatin Calcium  SciRegs
                               Tablets, EQ 5 mg      International,
                               base, EQ 10 mg        Inc., 6333
                               base, EQ 20 mg        Summercrest Dr.,
                               base, EQ 40 mg base.  Columbia, MD 21045.
ANDA 208199.................  Azelastine HCl        Amneal
                               Metered Spray,        Pharmaceuticals
                               0.2055 mg/spray.      LLC, 50 Horseblock
                                                     Rd., Brookhaven, NY
                                                     11719.
ANDA 210032.................  Azelastine HCl        Akorn Operating
                               Metered Spray,        Company LLC, 1925
                               0.2055 mg/spray.      West Field Ct.,
                                                     Suite 300, Lake
                                                     Forest, IL 60045.
ANDA 211461.................  Bosentan Tablets,     Syneos Health Global
                               62.5 mg and 125 mg.   Headquarters, 1030
                                                     Sync St., Third
                                                     Floor, Morrisville,
                                                     NC 27560.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of May 
25, 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 May 25, 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: April 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-08744 Filed 4-22-22; 8:45 am]
BILLING CODE 4164-01-P