83 FR 28856 - Novartis Pharmaceuticals Corporation, 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 120 (June 21, 2018)

The Food and Drug Administration (FDA or Agency) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 120 (Thursday, June 21, 2018)]
[Notices]
[Pages 28856-28857]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-13293]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2194]


Novartis Pharmaceuticals Corporation, 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 or Agency) 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that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of July 23, 2018.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 020831.............  Foradil Aerolizer        Novartis
                          (formoterol fumarate)    Pharmaceuticals
                          Powder, 0.012            Corp., One Health
                          milligram (mg)/          Pl., East Hanover, NJ
                          inhalation.              07936.
NDA 022504.............  Axiron (testosterone)    Eli Lilly and Co.,
                          Transdermal Metered      Lilly Corporate
                          Solution, 30 mg/1.5      Center, Indianapolis,
                          milliliter (mL)          IN 46285.
                          actuation.
NDA 050585.............  Rocephin (ceftriaxone    Hoffmann-La Roche,
                          sodium) for Injection,   Inc., c/o Genentech,
                          equivalent to (EQ) 10    Inc., 1 DNA Way,
                          gram (g) base/vial, EQ   South San Francisco,
                          250 mg base/vial (IV/    CA 94080.
                          IM), EQ 500 mg base/
                          vial (IV/IM), EQ 1 g
                          base/vial (IV/IM), EQ
                          2 g base/vial (IV/IM),
                          EQ 500 mg base/vial, N/
                          A; N/A, 1% (Rocephin
                          kit), EQ 1 g base/
                          vial, N/A; N/A, 1%
                          (Rocephin kit).
NDA 050624.............  Rocephin (ceftriaxone    Do.
                          sodium) with Dextrose
                          in Plastic Container
                          Injection, EQ 10 mg
                          base/mL, EQ 20 mg base/
                          mL, and EQ 40 mg base/
                          mL.
NDA 202763.............  Testosterone Gel, 25 mg/ ANI Pharmaceuticals,
                          2.5 g packet, 50 mg/5    Inc., 210 Main St.
                          g packet.                West, Baudette, MN
                                                   56623.
------------------------------------------------------------------------


[[Page 28857]]

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of July 
23, 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 July 23, 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: June 14, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-13293 Filed 6-20-18; 8:45 am]
 BILLING CODE 4164-01-P