83 FR 14016 - Mallinckrodt Inc. et al.; Withdrawal of Approval of Five New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 63 (April 2, 2018)

The Food and Drug Administration (FDA) is withdrawing approval of five new drug applications (NDAs) from multiple applicants. The holders of the applications notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

[Federal Register Volume 83, Number 63 (Monday, April 2, 2018)]
[Notices]
[Pages 14016-14017]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-06579]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1141]


Mallinckrodt Inc. et al.; Withdrawal of Approval of Five New Drug 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of five new drug applications (NDAs) from multiple applicants. The 
holders of the applications 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of the applications be withdrawn.

DATES: Approval is withdrawn as of May 2, 2018.

FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6248, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: The holders of the applications 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 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
------------------------------------------------------------------------
NDA 006383..................  Methadone             Mallinckrodt Inc.,
                               Hydrochloride (HCl)   675 McDonnell
                               Powder, 50 grams      Blvd., Hazelwood,
                               (g)/bottle, 100 g/    MO 63042.
                               bottle, and 500 g/
                               bottle.

[[Page 14017]]

 
NDA 020716..................  Vicoprofen            AbbVie Inc., 1 North
                               (hydrocodone          Waukegan Rd., North
                               bitartrate and        Chicago, IL 60064.
                               ibuprofen) Tablets,
                               7.5 milligrams (mg)/
                               200 mg.
NDA 021692..................  Ultram ER (tramadol   Valeant
                               HCl) Extended-        Pharmaceuticals
                               Release Tablets,      North America LLC,
                               100 mg, 200 mg, and   400 Somerset
                               300 mg.               Corporate Blvd.,
                                                     Bridgewater, NJ
                                                     08807.
NDA 207621..................  Troxyca ER            Pfizer Inc., 235
                               (oxycodone HCl and    East 42nd St., New
                               naltrexone HCl)       York, NY 10017.
                               Extended-Release
                               Capsules, 10 mg/1.2
                               mg, 20 mg/2.4 mg,
                               30 mg/3.6 mg, 40 mg/
                               4.8 mg, 60 mg/7.2
                               mg, and 80 mg/9.6
                               mg.
NDA 207975..................  Vantrela ER           Teva Branded
                               (hydrocodone          Pharmaceutical
                               bitartrate)           Products R&D, Inc.,
                               Extended-Release      41 Moores Rd., P.O.
                               Tablets, 15 mg, 30    Box 4011, Frazer,
                               mg, 45 mg, 60 mg,     PA 19355.
                               and 90 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of May 
2, 2018. 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 May 2, 2018 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: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06579 Filed 3-30-18; 8:45 am]
 BILLING CODE 4164-01-P