Document ID: FDA-2020-N-2088-0001
Agency: fda
Document Type: Notice
Title: Sanofi-Aventis U.S. LLC, et.al.; Withdrawal of Approval of 11
Abbreviated New Drug Applications
Posted Date: 2020-10-30T04:00Z

[Federal Register Volume 85, Number 211 (Friday, October 30, 2020)]
[Notices]
[Pages 68888-68889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24012]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2088]

Sanofi-Aventis U.S. LLC, et.al.; Withdrawal of Approval of 11 
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 11 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of November 30, 2020.

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.

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 061884.................  Rifamate (isoniazid   Sanofi-Aventis U.S.
                               and rifampin)         LLC 55 Corporate
                               Capsules, 150         Dr., Bridgewater,
                               milligrams (mg);      NJ 08807.
                               300 mg.
ANDA 065196.................  Ceftazidime for       Morton Grove
                               Injection, 1          Pharmaceuticals
                               gram(g)/vial.         Inc./Wockhardt USA
                                                     LLC., 6451 Main
                                                     St., Morton Grove,
                                                     IL 60053.
ANDA 065197.................  Cefotaxime for        Do.
                               Injection,
                               Equivalent to (EQ)
                               1 g base/vial; EQ 2
                               g base/vial; EQ 500
                               mg base/vial.
ANDA 078229.................  Terbinafine           Do.
                               Hydrochloride (HCl)
                               Tablets, EQ 250 mg
                               base.
ANDA 081134.................  Niacin Tablets, 500   Do.
                               mg.
ANDA 091659.................  Heparin Sodium        CASI
                               Injection, 5,000      Pharmaceuticals,
                               units/milliliter      Inc., 9620 Medical
                               (mL).                 Center Dr., Suite
                                                     300, Rockville, MD
                                                     20850.
ANDA 202647.................  Granisetron HCl       Yung Shin
                               Injection, EQ 0.1     Pharmaceutical
                               mg base/mL (EQ 0.1    Industrial Co.,
                               mg base/mL).          Ltd./Carlsbad
                                                     Technology, Inc.,
                                                     5922 Farnsworth
                                                     Ct., Carlsbad, CA
                                                     92008.
ANDA 202648.................  Granisetron HCl       Do.
                               Injection, EQ 1 mg
                               base/mL (EQ 1 mg
                               base/mL); EQ 4 mg
                               base/4 mL (EQ 1 mg
                               base/mL).
ANDA 205173.................  Bosentan Tablets,     Mylan
                               62.5 mg and 125 mg.   Pharmaceuticals
                                                     Inc., 781 Chestnut
                                                     Ridge Rd., P.O. Box
                                                     4310, Morgantown,
                                                     WV 26504.
ANDA 207843.................  Telmisartan Tablets,  Hisun Pharmaceutical
                               20 mg, 40 mg, and     (Hangzhou) Co.,
                               80 mg.                Ltd./Hisun
                                                     Pharmaceuticals
                                                     USA, Inc., 200
                                                     Crossing Blvd., 2nd
                                                     Floor, Bridgewater,
                                                     NJ 08807.

[[Page 68889]]

 
ANDA 210681.................  Ranitidine HCl        Novitium Pharma LLC,
                               Capsules, EQ 150 mg   70 Lake Dr., East
                               base and EQ 300 mg    Windsor, NJ 08520.
                               base.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
November 30, 2020. 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 November 30, 2020 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: October 26, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-24012 Filed 10-29-20; 8:45 am]
BILLING CODE 4164-01-P