83 FR 11208 - Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; Withdrawal of Approval of Four Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 50 (March 14, 2018)

The Food and Drug Administration (FDA) is withdrawing approval of four abbreviated new drug applications (ANDAs) from two 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 50 (Wednesday, March 14, 2018)]
[Notices]
[Page 11208]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-05120]



[[Page 11208]]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0793]


Sun Pharmaceutical Industries, Ltd., and Sun Pharma Global FZE; 
Withdrawal of Approval of Four Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of four abbreviated new drug applications (ANDAs) from two 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of the applications be withdrawn.

DATES: Approval is withdrawn as of April 13, 2018.

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 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
------------------------------------------------------------------------
ANDA 075556..................  Enalapril Maleate     Sun Pharmaceutical
                                Tablets USP, 2.5      Industries, Ltd.,
                                milligrams (mg), 5    c/o Sun
                                mg, 10 mg, and 20     Pharmaceutical
                                mg.                   Industries, Inc.,
                                                      2 Independence
                                                      Way, Princeton, NJ
                                                      08540.
ANDA 076045..................  Lorazepam Tablets     Do.
                                USP, 0.5 mg, 1 mg,
                                and 2 mg.
ANDA 078055..................  Zolpidem Tartrate     Do.
                                Tablets USP, 5 mg
                                and 10 mg.
ANDA 090018..................  Zoledronic Acid for   Sun Pharma Global
                                Injection,            FZE, c/o Sun
                                Equivalent to 4 mg    Pharmaceutical
                                base/vial.            Industries, Inc.,
                                                      2 Independence
                                                      Way, Princeton, NJ
                                                      08540.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of April 
13, 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 April 13, 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 8, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-05120 Filed 3-13-18; 8:45 am]
BILLING CODE 4164-01-P