Notice2022-08744
Baxter Healthcare Corporation, et al.; Withdrawal of Approval of 14 Abbreviated New Drug Applications
Primary source
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Published
April 25, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.
Full Text
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<title>Federal Register, Volume 87 Issue 79 (Monday, April 25, 2022)</title>
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[Federal Register Volume 87, Number 79 (Monday, April 25, 2022)]
[Notices]
[Pages 24320-24321]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-08744]
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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.
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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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of May 25, 2022.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, <a href="/cdn-cgi/l/email-protection#c588a4b7b1ada4eb8ba2b0bca0ab85a3a1a4ebadadb6eba2aab3"><span class="__cf_email__" data-cfemail="4b062a393f232a65052c3e322e250b2d2f2a65232338652c243d">[email protected]</span></a>.
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]]
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Application No. Drug Applicant
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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.
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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
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