[Federal Register Volume 85, Number 239 (Friday, December 11, 2020)]
[Notices]
[Page 80119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2197]


VistaPharm, Inc., et al.; Withdrawal of Approval of 10 
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 10 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of January 11, 2021.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, 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 040323...................  Prednisolone Syrup, 15  VistaPharm,
                                 milligrams (mg)/5       Inc., 7265
                                 milliliters (mL).       Ulmerton Rd.,
                                                         Largo, FL 33771
ANDA 075782...................  Valproic Acid Syrup,     Do.
                                 250 mg/5 mL.
ANDA 076188...................  Fosinopril Sodium       Upsher-Smith
                                 Tablets, 10 mg, 20      Laboratories,
                                 mg, and 40 mg.          LLC, 6701
                                                         Evenstad Dr.,
                                                         Maple Grove, MN
                                                         55369
ANDA 076189...................  Mirtazapine Tablets,     Do.
                                 15 mg, 30 mg, and 45
                                 mg.
ANDA 077537...................  Glyburide Tablets,      Aurobindo Pharma
                                 1.25 mg, 2.5 mg, and    USA, Inc., 279
                                 5 mg.                   Princeton-
                                                         Hightstown Rd.,
                                                         East Windsor,
                                                         NJ 08520
ANDA 077672...................  Stavudine Capsules, 15   Do.
                                 mg, 20 mg, 30 mg, and
                                 40 mg.
ANDA 085055...................  Tylenol W/Codeine No.   Janssen
                                 1 (acetaminophen and    Pharmaceuticals
                                 codeine phosphate)      , Inc., 1000
                                 Tablets, 300 mg; 7.5    U.S. Route 202,
                                 mg.                     P.O. Box 300,
                                Tylenol W/Codeine No.    Raritan NJ
                                 2 (acetaminophen and    08869
                                 codeine phosphate)
                                 Tablets, 300 mg; 15
                                 mg.
                                Tylenol W/Codeine No.
                                 3 (acetaminophen and
                                 codeine phosphate)
                                 Tablets, 300 mg; 30
                                 mg.
                                Tylenol W/Codeine No.
                                 4 (acetaminophen and
                                 codeine phosphate)
                                 Tablets, 300 mg; 60
                                 mg.
ANDA 087266...................  Lindane Shampoo, 1%...  Olta
                                                         Pharmaceuticals
                                                         Corp. (an Akorn
                                                         Company), 1925
                                                         West Field Ct.,
                                                         Suite 300, Lake
                                                         Forest, IL
                                                         60045
ANDA 087313...................  Lindane Lotion, 1%....   Do.
ANDA 089003...................  Phenytoin Sodium        Fresenius Kabi
                                 Injection, 50 mg/mL.    USA, LLC, Three
                                                         Corporate Dr.,
                                                         Lake Zurich, IL
                                                         60047
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
January 11, 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 January 11, 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: December 8, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-27303 Filed 12-10-20; 8:45 am]
BILLING CODE 4160-01-P


