Fresenius Kabi USA, LLC, et al.; Withdrawal of Approval of 15 Abbreviated New Drug Applications, 40591-40592 [2021-16047]

Download as PDF Federal Register / Vol. 86, No. 142 / Wednesday, July 28, 2021 / Notices or via regular mail if email is not an option. Invoices must be paid within 30 days. C. Fee Payment Procedures 1. The preferred payment method is online using electronic check (Automated Clearing House (ACH) also known as eCheck) or credit card (Discover, VISA, MasterCard, American Express). Secure electronic payments can be submitted using the User Fees Payment Portal at—https:// userfees.fda.gov/pay. (Note: only full payments are accepted. No partial payments can be made online.) Once you search for your invoice, click ‘‘Pay Now’’ to be redirected to Pay.gov. Electronic payment options are based on the balance due. Payment by credit card is available for balances less than $25,000. If the balance exceeds this amount, only the ACH option is available. Payments must be made using U.S. bank accounts as well as U.S. credit cards. 2. If paying with a paper check: Checks must be in U.S. currency from a U.S. bank and made payable to the Food and Drug Administration. Payments can be mailed to: Food and Drug Administration, P.O. Box 979033, St. Louis, MO 63197–9000. Include invoice number on check. If a check is sent by a courier that requests a street address, the courier can deliver the check to: U.S. Bank, Attn: Government Lockbox 979033, 1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank address is for courier delivery only. If you have any questions concerning courier delivery, contact the U.S. Bank at 314–418–4013). 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. SUMMARY: Approval is withdrawn as of August 27, 2021.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 ...................... khammond on DSKJM1Z7X2PROD with NOTICES 3. When paying by wire transfer, the invoice number must be included. Without the invoice number the payment may not be applied. Regarding reinspection fees, if the payment amount is not applied, the invoice amount will be referred to collections. The originating financial institution may charge a wire transfer fee. If the financial institution charges a wire 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 ...................... VerDate Sep<11>2014 17:16 Jul 27, 2021 Jkt 253001 PO 00000 Frm 00148 Fmt 4703 Sfmt 4703 E:\FR\FM\28JYN1.SGM 28JYN1 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 khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 17:16 Jul 27, 2021 Jkt 253001 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 PO 00000 Frm 00149 Fmt 4703 Sfmt 4703 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 E:\FR\FM\28JYN1.SGM 28JYN1

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]


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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.

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

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