Document ID: FDA-2020-N-1081-0001
Agency: fda
Document Type: Notice
Title: Hospira Inc., et al.; Withdrawal of Approval of Seven Abbreviated New
Drug Applications
Posted Date: 2020-05-12T04:00Z

[Federal Register Volume 85, Number 92 (Tuesday, May 12, 2020)]
[Notices]
[Pages 28016-28017]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10082]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1081]

Hospira Inc., et al.; Withdrawal of Approval of Seven 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 seven abbreviated new drug applications (ANDAs) 
from multiple applicants. The

[[Page 28017]]

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be withdrawn.

DATES: Approval is withdrawn as of June 11, 2020.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 065232.................  Ceftriaxone Sodium    Hospira Inc., 275
                               for Injection,        North Field Dr.,
                               Equivalent to (EQ)    Building H1, Lake
                               10 grams (g) base/    Forest, IL 60045.
                               vial.
ANDA 088697.................  Amitriptyline         Par Pharmaceutical
                               Hydrochloride (HCl)   Inc., One Ram Ridge
                               Tablets, 10           Rd., Spring Valley,
                               milligrams (mg).      NY 10977.
ANDA 088698.................  Amitriptyline HCl     Par Pharmaceutical
                               Tablets, 25 mg.       Inc.
ANDA 088699.................  Amitriptyline HCl     Do.
                               Tablets, 50 mg.
ANDA 088700.................  Amitriptyline HCl     Do.
                               Tablets, 75 mg.
ANDA 088701.................  Amitriptyline HCl     Do.
                               Tablets, 100 mg.
ANDA 088702.................  Amitriptyline HCl     Do.
                               Tablets, 150 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of June 
11, 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 June 11, 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: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10082 Filed 5-11-20; 8:45 am]
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