Document ID: FDA-2019-N-0163-0001
Agency: fda
Document Type: Notice
Title: Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug
Applications
Posted Date: 2019-02-12T05:00Z

[Federal Register Volume 84, Number 29 (Tuesday, February 12, 2019)]
[Notices]
[Pages 3467-3468]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02032]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0163]

Hospira, Inc., et al.; Withdrawal of Approval of 12 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 12 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of March 14, 2019.

FOR FURTHER INFORMATION CONTACT: Trang Tran, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 75, Rm. 1671, Silver Spring, MD 20993-0002, 240-402-7945, 
Trang.Tran@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 065343.................  Epirubicin            Hospira, Inc., 275
                               Hydrochloride (HCl)   North Field Dr.,
                               Injection USP, 10     Bldg. H1, Lake
                               milligrams (mg)/5     Forest, IL 60045.
                               milliliters (mL),
                               50 mg/25 mL, 150 mg/
                               75 mL, and 200 mg/
                               100 mL.
ANDA 070562.................  Flurazepam HCl        Pharmaceutical
                               Capsules USP, 15 mg.  Basics, Inc., 301
                                                     South Cherokee St.,
                                                     Denver, CO 80223.
ANDA 070563.................  Flurazepam HCl        Do.
                               Capsules USP, 30 mg.
ANDA 071808.................  Flurazepam HCl        Halsey Drug Co.,
                               Capsules USP, 15 mg.  Inc., 1827 Pacific
                                                     St., Brooklyn, NY
                                                     11233.
ANDA 071809.................  Flurazepam HCl        Do.
                               Capsules USP, 30 mg.
ANDA 076827.................  Vinorelbine           Hospira, Inc.
                               Injection USP,
                               Equivalent to 10 mg
                               base/mL.
ANDA 077736.................  Polyethylene Glycol   Breckenridge
                               3350 Powder for       Pharmaceutical,
                               Oral Solution, 17     Inc., 6111 Broken
                               grams/scoopful.       Sound Parkway NW,
                                                     Suite 170, Boca
                                                     Raton, FL 33487.
ANDA 085763.................  Glutethimide          Chelsea
                               Tablets, 500 mg.      Laboratories, Inc.,
                                                     896 Orlando Ave.,
                                                     West Hampstead, NY
                                                     11552.
ANDA 085791.................  Pentobarbital Sodium  Do.
                               Capsules, 100 mg.
ANDA 087297.................  Glutethimide          Phoenix
                               Tablets, 500 mg.      Pharmaceuticals,
                                                     Inc., 111 Leuning
                                                     St., South
                                                     Hackensack, NJ
                                                     07606.
ANDA 088819.................  Aristocort A          Astellas Pharma
                               (triamcinolone        U.S., Inc., Three
                               acetonide) Cream,     Parkway North,
                               0.1%.                 Deerfield, IL
                                                     60015.
ANDA 089459.................  Glutethimide          Halsey Drug Co.,
                               Tablets, 500 mg.      Inc.
------------------------------------------------------------------------

[[Page 3468]]

    Therefore, approval of the applications listed in the table and all 
amendments and supplements thereto, are hereby withdrawn as of March 
14, 2019. 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 14, 2019 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 7, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02032 Filed 2-11-19; 8:45 am]
BILLING CODE 4164-01-P