[Federal Register Volume 85, Number 35 (Friday, February 21, 2020)]
[Notices]
[Page 10177]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-03512]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-6083]


Hospira, Inc., et al.; Withdrawal of Approval of 15 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 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of March 23, 2020.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 040372...............  Promethazine           Hospira, Inc., 275
                             Hydrochloride (HCl)    North Field Dr.,
                             Injection, 25          Bldg. H1, Lake
                             milligrams (mg)/       Forest, IL 60045.
                             milliliter (mL) and
                             50 mg/mL.
ANDA 062791...............  Cephalexin Capsules,   Sun Pharmaceutical
                             Equivalent to (EQ)     Industries, Inc., 2
                             250 mg base and 500    Independence Way,
                             mg base.               Princeton, NJ 08540.
ANDA 065226...............  Cefazolin Sodium for   Hospira, Inc.
                             Injection, EQ 500 mg
                             base/vial and EQ 1
                             gram (g) base/vial.
ANDA 065244...............  Cefazolin Sodium for   Do.
                             Injection, EQ 1 g
                             base/vial.
ANDA 065375...............  Cefotetan Disodium     Fresenius Kabi USA,
                             for Injection, EQ 10   LLC., Three
                             g base/vial.           Corporate Dr., Lake
                                                    Zurich, IL 60047.
ANDA 065386...............  Piperacillin Sodium    Hospira, Inc.
                             and Tazobactam
                             Sodium for
                             Injection, EQ 2 g
                             base/vial; EQ 250 mg
                             base/vial, EQ 3 g
                             base/vial; EQ 375 mg
                             base/vial, EQ 4 g
                             base/vial; EQ 500 mg
                             base/vial.
ANDA 065446...............  Piperacillin Sodium    Do.
                             and Tazobactam
                             Sodium for
                             Injection, EQ 36 g
                             base/vial; EQ 4.5 g
                             base/vial.
ANDA 075955...............  Amiodarone HCl         Do.
                             Injection, 50 mg/mL.
ANDA 076124...............  Ranitidine HCl Syrup,  Actavis Mid Atlantic,
                             EQ 15 mg base/mL.      LLC., Subsidiary of
                                                    Teva Pharmaceuticals
                                                    USA, Inc., 400
                                                    Interpace Pkwy.,
                                                    Morris Corporate
                                                    Center III, Bldg. A,
                                                    Third Floor,
                                                    Parsippany, NJ
                                                    07054.
ANDA 076722...............  Ketorolac              INC Research, LLC.,
                             Tromethamine           4800 Falls of Neuse
                             Injection, 15 mg/mL,   Rd., Suite 600,
                             30 mg/mL, and 60 mg/   Raleigh, NC 27609.
                             mL.
ANDA 080700...............  Chlorpheniramine       Sun Pharmaceutical
                             Maleate Tablets, 4     Industries, Inc.
                             mg.
ANDA 083201...............  Hydrocortisone         Crown Laboratories,
                             Lotion, 1%.            Inc., 349 Lafe Cox
                                                    Dr., Johnson City,
                                                    TN 37604.
ANDA 201654...............  Cefazolin Sodium for   Hospira, Inc.
                             Injection, EQ 1 g
                             base/vial.
ANDA 203950...............  Oxacillin Sodium for   Do.
                             Injection, EQ 1 g
                             base/vial and EQ 2 g
                             base/vial.
ANDA 207731...............  Nystatin and           Crown Laboratories,
                             Triamcinolone          Inc.
                             Acetonide Ointment,
                             100,000 units/g;
                             0.1%.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of March 
23, 2020. Approval of each entire application is withdrawn, including 
any strengths or products 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 March 23, 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: February 18, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-03512 Filed 2-20-20; 8:45 am]
BILLING CODE 4164-01-P


