[Federal Register Volume 84, Number 112 (Tuesday, June 11, 2019)]
[Notices]
[Page 27128]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12287]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1740]


Novartis Pharmaceuticals Corp., et al.; Withdrawal of Approval of 
Six 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 six 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of July 11, 2019.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, 
[email protected].

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 070185...............  Fluor-Op               Novartis
                             (fluorometholone)      Pharmaceuticals
                             Ophthalmic             Corp., One Health
                             Suspension, 0.1%.      Plaza, East Hanover,
                                                    NJ 07936.
ANDA 070858...............  Trazodone              Watson Laboratories,
                             Hydrochloride          Inc., Subsidiary of
                             Tablets USP, 100       Teva Pharmaceuticals
                             milligrams (mg).       USA, Inc., 425
                                                    Privet Rd., Horsham,
                                                    PA 19044.
ANDA 076023...............  Hydrocodone            Teva Pharmaceuticals
                             Bitartrate and         USA, Inc., 400
                             Ibuprofen Tablets,     Interpace Pkwy.,
                             7.5 mg/200 mg.         Bldg. A, Parsippany,
                                                    NJ 07054.
ANDA 078167...............  Paclitaxel Injection   Sandoz, Inc., 100
                             USP, 6 mg/milliliter.  College Rd. West,
                                                    Princeton, NJ 08540.
ANDA 088726...............  Chlorpropamide         Aurolife Pharma, LLC,
                             Tablets USP, 250 mg.   279 Princeton
                                                    Hightstown Rd., East
                                                    Windsor, NJ 08520.
ANDA 089852...............  Chlorzoxazone Tablets  Do.
                             USP, 250 mg.
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    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of July 
11, 2019. 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 July 11, 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: June 6, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12287 Filed 6-10-19; 8:45 am]
 BILLING CODE 4164-01-P