Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications, 40591-40592 [2021-16047]
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Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices
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Dated: July 20, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–16057 Filed 7–27–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0652]
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applications be withdrawn.
SUMMARY:
Approval is withdrawn as of
August 27, 2021.
DATES:
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, Martha.Nguyen@fda.hhs.gov.
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 § 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
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Fresenius Kabi USA, LLC, et al.;
Withdrawal of Approval of 15
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
Application No.
Drug
ANDA 040265 ......................
ANDA 070963 ......................
Methotrexate Sodium Injection, Equivalent to (EQ) 25
milligrams (mg) base/milliliters (mL).
Clonidine Hydrochloride (HCl) Tablets, 0.3 mg ..............
ANDA 074292 ......................
Dobutamine HCl Injection, EQ 12.5 mg base/mL ..........
ANDA 075069 ......................
ANDA 075856 ......................
Etodolac Tablets, 400 mg ...............................................
Midazolam HCl Injection, EQ 1 mg base/mL and EQ 5
mg base/mL.
Hydralazine HCl Tablets, 25 mg .....................................
Budesonide Delayed Release Capsules, 3 mg ..............
ANDA 084504 ......................
ANDA 090379 ......................
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amount will be referred to collections.
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may charge a wire transfer fee. If the
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transfer fee, it is required that the
outsourcing facility add that amount to
the payment to ensure that the invoice
is paid in full. Use the following
account information when sending a
wire transfer: U.S. Dept of the Treasury,
TREAS NYC, 33 Liberty St., New York,
NY 10045, Acct. No. 75060099, Routing
No. 021030004, SWIFT: FRNYUS33. If
needed, FDA’s tax identification
number is 53–0196965.
40591
Applicant
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake
Zurich, IL 60047.
Watson Laboratories, Inc. (an indirect, wholly owned
subsidiary of Teva Pharmaceuticals USA, Inc.), 400
Interpace Pkwy., Bldg. A, Parsippany, NJ 07054.
Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.
Watson Laboratories, Inc.
Hospira, Inc.
Watson Laboratories, Inc.
Barr Laboratories, Inc. (an indirect, wholly owned subsidiary of Teva Pharmaceuticals USA, Inc.), 400
Interpace Pkwy., Bldg. A, Morris Corporate Center III,
Parsippany, NJ 07054.
Mylan Pharmaceuticals Inc., a Viatris Company, 81
Chestnut Ridge Rd., P.O. Box 4310, Morgantown,
WV 26504.
Do.
ANDA 091590 ......................
Losartan Potassium Tablets, 25 mg, 50 mg, and 100
mg.
ANDA 091652 ......................
Hydrochlorothiazide and Losartan Potassium Tablets,
12.5 mg/50 mg, 12.5 mg/100 mg, and 25 mg/100 mg.
Eptifibatide Injection, 2 mg/mL and 75 mg/100 mL ........ USV Private Limited, U.S. Agent, Omega Pharmaceutical Consulting, Inc., 752 West Shuhthagi Lane,
New Harmony, UT 84757.
Eptifibatide Injection, 2 mg/mL ........................................ Do.
ANDA 204361 ......................
ANDA 204362 ......................
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17:16 Jul 27, 2021
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40592
Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices
Application No.
Drug
Applicant
ANDA 204464 ......................
Sodium Fluoride F–18 Injection, 10–200 millicurie/mL ...
ANDA 206177 ......................
Docetaxel Injection, 20 mg/mL (20 mg/mL), 80 mg/4
mL (20 mg/mL), and 200 mg/10 mL (20 mg/mL).
Olmesartan Medoxomil Tablets, 5 mg, 20 mg, and 40
mg.
Decatur Memorial Hospital, 2300 North Edward St.,
Suite 100, Decatur, IL 62526.
DFB Oncology, LLC, 3909 Hulen St., Fort Worth, TX
76107.
Lupin Limited, U.S. Agent, Lupin Pharmaceuticals, Inc.,
111 South Calvert St., Harborplace Tower, 21st
Floor, Baltimore, MD 21202.
Jiangsu Hansoh Pharmaceutical Group Co., Ltd., U.S.
Agent, eVenus Pharmaceutical Laboratories Inc., 506
Carnegie Center, Suite 100, Princeton, NJ 08540.
ANDA 206631 ......................
ANDA 209399 ......................
Olanzapine Tablets, 2.5 mg, 5 mg, and 10 mg ..............
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–N–2169]
Jacobo Geissler: Final Debarment
Order
Food and Drug Administration,
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) debarring
Jacobo Geissler for a period of 5 years
from importing articles of food or
offering such articles for importation
into the United States. FDA bases this
order on a finding that Mr. Geissler was
convicted of a felony count under
Federal law for conduct relating to the
importation into the United States of an
article of food. Mr. Geissler was given
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SUMMARY:
VerDate Sep<11>2014
17:16 Jul 27, 2021
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notice of the proposed debarment and
an opportunity to request a hearing
within the timeframe prescribed by
regulation. As of April 7, 2021 (30 days
after receipt of the notice), Mr. Geissler
has not responded. Mr. Geissler’s failure
to respond and request a hearing
constitutes a waiver of Mr. Geissler’s
right to a hearing concerning this
matter.
DATES: This order is applicable July 28,
2021.
ADDRESSES: Submit applications for
termination of debarment to the Dockets
Management Staff, Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, 240–402–
7500, or at https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Jaime Espinosa, Division of Enforcement
(ELEM–4029), Office of Strategic
Planning and Operational Policy, Office
of Regulatory Affairs, Food and Drug
Administration, 12420 Parklawn Dr.,
Rockville, MD 20857, 240–402–8743, or
at debarments@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
Section 306(b)(1)(C) of the FD&C Act
(21 U.S.C. 335a(b)(1)(C)) permits FDA to
debar an individual from importing an
article of food or offering such an article
for import into the United States if FDA
finds, as required by section
306(b)(3)(A) of the FD&C Act, that the
individual has been convicted of a
felony for conduct relating to the
importation into the United States of
any food.
On October 13, 2020, Mr. Geissler was
convicted as defined in section
306(l)(1)(A) of the FD&C Act (21 U.S.C.
335a(l)(1)(A)), in the U.S. District Court
for the Northern District of Texas-Dallas
Division, when the court accepted his
plea of guilty and entered judgment
against him for the offense of conspiracy
to introduce misbranded food into
interstate commerce with an intent to
defraud and mislead in violation of 18
U.S.C. 371 (21 U.S.C. 331(a) and 21
U.S.C. 333(a)(2)).
FDA’s finding that the debarment is
appropriate is based on the felony
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conviction referenced herein. The
factual basis for this conviction is as
follows: As contained in the Factual
Resume, dated February 24, 2019, in Mr.
Geissler’s case, he was the Chief
Executive Officer (CEO) and coowner of
USPlabs, LLC (USP Labs). USP Labs
sold dietary supplements. Beginning in
or around October 2008 and continuing
until at least around August 2014, Mr.
Geissler engaged in a conspiracy with
others to import a variety of chemicals
with false labeling in order to either use
those chemicals in dietary supplements
which would themselves also contain
false labeling, or to determine whether
those chemicals could be used in new
dietary supplements. To further this
conspiracy, Mr. Geissler’s
coconspirators ordered chemicals from a
Chinese company to be used as
ingredients in dietary supplements and
had them labeled falsely as other food
substances. USP Labs sold dietary
supplements called Jack3d and OxyElite
Pro, which originally contained a
substance called 1,3-dimethylamine
(DMAA), which is also known as
methylhexaneamine. USP Labs
imported the DMAA it used in its
products, Jack3d and OxyElite Pro, from
a Chinese chemical factory by using
false and fraudulent Certificate of
Analysis (COA) and other false and
fraudulent documentation and labeling.
At least some of the false COAs that
USP Labs caused to be created for their
DMAA shipments stated falsely that the
substance in the shipments had been
extracted from the geranium plant.
Further, as contained in the factual
resume and superseding indictment,
filed January 5, 2016, in December 2011,
Mr. Geissler instructed a Chinese
company via email to misbrand a
shipment of nine different chemicals
sent from China to USP Labs in Texas.
One of those synthetic chemicals was
called ‘‘aegeline.’’ The first aegeline
containing version of OxyElite Pro,
which was called OxyElite ‘‘New
Formula’’, went on sale in December
2012, but did not sell as well as the
DMAA-containing version. Therefore, in
the summer 2013, USP Labs began using
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]]>Agencies
[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40591-40592]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16047]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, [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 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.
------------------------------------------------------------------------
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
