Document ID: FDA-2021-N-1195-0001
Agency: fda
Document Type: Notice
Title: Discovery Therapeutics, LLC, et al.; Withdrawal of Approval of 18 Abbreviated New Drug Applications
Posted Date: 2021-11-18T05:00Z

[Federal Register Volume 86, Number 220 (Thursday, November 18, 2021)]
[Notices]
[Page 64506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-25111]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-1195]

Discovery Therapeutics, LLC, et al.; Withdrawal of Approval of 18 
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 18 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of December 20, 2021.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]s.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 040619...............  Methimazole Tablets,   Discovery
                             15 milligrams (mg).    Therapeutics, LLC,
                                                    2831 Deer Hound Way,
                                                    Palm Harbor, FL
                                                    34683.
ANDA 070254...............  Naloxone               Hospira, Inc., 275
                             Hydrochloride (HCl)    North Field Dr.,
                             Injection, 0.4 mg/     Building H1, Lake
                             milliliters (mL).      Forest, IL 60045.
ANDA 070586...............  Bupivacaine HCl        Do.
                             Injection, 0.25%.
ANDA 071850...............  Morphine Sulfate       Do.
                             Injection, 1 mg/mL.
ANDA 075220...............  Desmopressin Acetate   Do.
                             Injection, 0.004 mg/
                             mL.
ANDA 076498...............  Tretinoin Cream,       ZO Skin Health, Inc.,
                             0.05%.                 9685 Research Dr.,
                                                    Irvine, CA 92618.
ANDA 077245...............  Ciprofloxacin          Hospira, Inc.
                             Injection, 200 mg/20
                             mL (10 mg/mL) and
                             400 mg/40 mL (10 mg/
                             mL).
ANDA 080409...............  Lidocaine HCl          Do.
                             Solution, 4%.
ANDA 087446...............  Chloroprocaine HCl     Do.
                             Injection, 3%.
ANDA 087447...............  Chloroprocaine HCl     Do.
                             Injection, 2%.
ANDA 201653...............  Levocetirizine         Sun Pharmaceutical
                             Dihydrochloride        Industries, Inc.,
                             Tablets, 5 mg.         U.S. Agent for Sun
                                                    Pharmaceutical
                                                    Industries Ltd., 270
                                                    Prospect Plains Rd.,
                                                    Cranbury, NJ 08512.
ANDA 202524...............  Levetiracetam          Rouses Point
                             Extended Release       Pharmaceuticals,
                             Tablets, 500 mg and    LLC, 11 Commerce
                             750 mg.                Dr., Cranford, NJ
                                                    07016.
ANDA 202857...............  Daptomycin Powder for  Hospira, Inc.
                             Injection, 500 mg/
                             vial.
ANDA 203885...............  Amiodarone HCl         Do.
                             Injection, 50 mg/mL.
ANDA 207864...............  Eptifibatide           The WhiteOak Group,
                             Injection, 2 mg/mL     LLC, U.S. Agent for
                             and 75 mg/100 mL.      Hybio Pharmaceutical
                                                    Co., Ltd., 1629 K
                                                    St. NW, Suite 300,
                                                    Washington, DC
                                                    20006.
ANDA 209489...............  Caspofungin Acetate    Cipla USA, Inc., U.S.
                             Powder for             Agent for Cipla
                             Injection, 50 mg/      Limited, 10
                             vial and 70 mg/vial.   Independence Blvd.,
                                                    Suite 300, Warren,
                                                    NJ 07059.
ANDA 210283...............  Clofarabine            Hospira, Inc.
                             Injection, 20 mg/20
                             mL (1 mg/mL).
ANDA 210855...............  Sodium Nitroprusside   Cipla USA, Inc.
                             Injection, 25 mg/mL.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
December 20, 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 December 20, 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: November 12, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25111 Filed 11-17-21; 8:45 am]
BILLING CODE 4164-01-P