Document ID: FDA-2019-N-2040-0001
Agency: fda
Document Type: Notice
Title: Liebel-Flarsheim Company LLC, et al.; Withdrawal of Approval of 11 New
Drug Applications
Posted Date: 2019-07-03T04:00Z

[Federal Register Volume 84, Number 128 (Wednesday, July 3, 2019)]
[Notices]
[Pages 31872-31873]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14219]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-2040]

Liebel-Flarsheim Company LLC, et al.; Withdrawal of Approval of 
11 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 11 new drug applications (NDAs) 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applications be withdrawn.

DATES: Approval is withdrawn as of August 2, 2019.

FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.

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 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 016983................  Conray 30              Liebel-Flarsheim Co.
                             (iothalamate           LLC, 1034 South
                             meglumine)             Brentwood Blvd.,
                             Injection, 30%.        Suite 800, Richmond
                                                    Heights, MO 63117.
NDA 018972................  Cordarone (amiodarone  Wyeth Pharmaceuticals
                             HCl) Tablets, 200 mg.  LLC, P.O. Box 8299,
                                                    Philadelphia, PA
                                                    19101-8299.
NDA 019009................  Maxair Inhaler         Bausch Health US,
                             (pirbuterol acetate    LLC, 400 Somerset
                             inhalation aerosol),   Corporate Blvd.,
                             equivalent to (EQ)     Bridgewater, NH
                             0.2 mg base/           08807.
                             inhalation.

[[Page 31873]]

 
NDA 019292................  MD-76R (diatrizoate    Liebel-Flarsheim Co.
                             meglumine and          LLC.
                             diatrizoate sodium)
                             Injection, 66%/10%.
NDA 020014................  Maxair Autohaler       Bausch Health US,
                             (pirbuterol acetate    LLC.
                             inhalation aerosol),
                             EQ 0.2 mg base/
                             inhalation.
NDA 021041................  DepoCyt (cytarabine    Pacira
                             liposome) Injection,   Pharmaceuticals,
                             10 mg/mL.              Inc., 5 Sylvan Way,
                                                    Suite 300,
                                                    Parsippany, NJ
                                                    07054.
NDA 021338................  Ionsys (fentanyl       The Medicines Co., 8
                             iontophoresis          Sylvan Way,
                             transdermal system),   Parsippany, NJ
                             40 mcg/activation.     07054.
NDA 021575................  Fosamax (alendronate   Merck Sharp & Dohme
                             sodium) Oral           Corp., 1 Merck Dr.,
                             Solution, EQ 70 mg     P.O. Box 100,
                             base/75 mL.            Whitehouse Station,
                                                    NJ 08889-0100.
NDA 022222................  Ultresa (pancrelipase  Allergan Sales, LLC,
                             (amylase, lipase,      5 Giralda Farms,
                             protease)), Delayed-   Madison, NJ 07940.
                             Release Capsules,
                             8,000 USP Units/
                             4,000 USP Units/
                             8,000 USP Units and
                             27,600 USP Units/
                             13,800 USP Units/
                             27,600 USP Units,
                             and 41,400 USP Units/
                             20,700 USP Units/
                             41,400 USP Units,
                             and 46,000 USP Units/
                             23,000 USP Units/
                             46,000 USP Units.
NDA 022396................  Dyloject (diclofenac   Javelin
                             sodium) Injection,     Pharmaceuticals,
                             37.5 mg/mL.            Inc., a subsidiary
                                                    of Hospira Inc., 275
                                                    North Field Dr.,
                                                    Dept. 0392, Bldg. H1-
                                                    3S, Lake Forest, IL
                                                    60045.
NDA 203568................  Kynamro (mipomersen    Kastle Therapeutics,
                             sodium) Injection,     181 West Madison
                             200 mg/mL.             St., Suite 300,
                                                    Chicago, IL 60602.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
August 2, 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 August 2, 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 28, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14219 Filed 7-2-19; 8:45 am]
 BILLING CODE 4164-01-P