Notice2021-16047
Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 28, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 15 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 86 Issue 142 (Wednesday, July 28, 2021)</title>
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[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40591-40592]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-16047]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2021-N-0652]
Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of 15
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 15 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of August 27, 2021.
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#bef3dfcccad6df90f0d9cbc7dbd0fed8dadf90d6d6cd90d9d1c8"><span class="__cf_email__" data-cfemail="7f321e0d0b171e5131180a061a113f191b1e5117170c51181009">[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.
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Application No. Drug Applicant
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ANDA 040265................. Methotrexate Sodium Fresenius Kabi USA,
Injection, LLC, Three
Equivalent to (EQ) Corporate Dr., Lake
25 milligrams (mg) Zurich, IL 60047.
base/milliliters
(mL).
ANDA 070963................. Clonidine Watson Laboratories,
Hydrochloride (HCl) Inc. (an indirect,
Tablets, 0.3 mg. wholly owned
subsidiary of Teva
Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Bldg. A,
Parsippany, NJ
07054.
ANDA 074292................. Dobutamine HCl Hospira, Inc., 275
Injection, EQ 12.5 North Field Dr.,
mg base/mL. Bldg. H1, Lake
Forest, IL 60045.
ANDA 075069................. Etodolac Tablets, Watson Laboratories,
400 mg. Inc.
ANDA 075856................. Midazolam HCl Hospira, Inc.
Injection, EQ 1 mg
base/mL and EQ 5 mg
base/mL.
ANDA 084504................. Hydralazine HCl Watson Laboratories,
Tablets, 25 mg. Inc.
ANDA 090379................. Budesonide Delayed Barr Laboratories,
Release Capsules, 3 Inc. (an indirect,
mg. wholly owned
subsidiary of Teva
Pharmaceuticals
USA, Inc.), 400
Interpace Pkwy.,
Bldg. A, Morris
Corporate Center
III, Parsippany, NJ
07054.
ANDA 091590................. Losartan Potassium Mylan
Tablets, 25 mg, 50 Pharmaceuticals
mg, and 100 mg. Inc., a Viatris
Company, 81
Chestnut Ridge Rd.,
P.O. Box 4310,
Morgantown, WV
26504.
ANDA 091652................. Hydrochlorothiazide Do.
and Losartan
Potassium Tablets,
12.5 mg/50 mg, 12.5
mg/100 mg, and 25
mg/100 mg.
ANDA 204361................. Eptifibatide USV Private Limited,
Injection, 2 mg/mL U.S. Agent, Omega
and 75 mg/100 mL. Pharmaceutical
Consulting, Inc.,
752 West Shuhthagi
Lane, New Harmony,
UT 84757.
ANDA 204362................. Eptifibatide Do.
Injection, 2 mg/mL.
[[Page 40592]]
ANDA 204464................. Sodium Fluoride F-18 Decatur Memorial
Injection, 10-200 Hospital, 2300
millicurie/mL. North Edward St.,
Suite 100, Decatur,
IL 62526.
ANDA 206177................. Docetaxel Injection, DFB Oncology, LLC,
20 mg/mL (20 mg/ 3909 Hulen St.,
mL), 80 mg/4 mL (20 Fort Worth, TX
mg/mL), and 200 mg/ 76107.
10 mL (20 mg/mL).
ANDA 206631................. Olmesartan Medoxomil Lupin Limited, U.S.
Tablets, 5 mg, 20 Agent, Lupin
mg, and 40 mg. Pharmaceuticals,
Inc., 111 South
Calvert St.,
Harborplace Tower,
21st Floor,
Baltimore, MD
21202.
ANDA 209399................. Olanzapine Tablets, Jiangsu Hansoh
2.5 mg, 5 mg, and Pharmaceutical
10 mg. Group Co., Ltd.,
U.S. Agent, eVenus
Pharmaceutical
Laboratories Inc.,
506 Carnegie
Center, Suite 100,
Princeton, NJ
08540.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
August 27, 2021. 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 August 27, 2021 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: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16047 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P
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