83 FR 48635 - Aurolife Pharma, LLC, et al.; Withdrawal of Approval of Seven Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 187 (September 26, 2018)

The Food and Drug Administration (FDA or Agency) is withdrawing approval of seven 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

[Federal Register Volume 83, Number 187 (Wednesday, September 26, 2018)]
[Notices]
[Pages 48635-48636]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-20947]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3463]


Aurolife Pharma, LLC, et al.; Withdrawal of Approval of Seven 
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 seven 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of October 26, 2018.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 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 072112.................  Clorazepate           Aurolife Pharma,
                               Dipotassium           LLC, 279 Princeton
                               Capsules, 3.75        Hightstown Rd.,
                               milligrams (mg),      East Windsor, NJ
                               7.5 mg, and 15 mg.    08520.
ANDA 074863.................  Clemastine Fumarate   Workhardt Bio AG, c/
                               Syrup, Equivalent     o Morton Grove
                               to (EQ) 0.5 mg base/  Pharmaceuticals,
                               5 milliliters (mL).   Inc., 6451 Main
                                                     St., Morton Grove,
                                                     IL 60053.
ANDA 080925.................  Isocaine 3%           Septodont, Inc., c/o
                               (mepivacaine          Arent Fox, LLP,
                               hydrochloride         1717 K St. NW,
                               (HCl)) Injection      Washington, DC
                               USP, 3%.              20006.
ANDA 084048.................  Octocaine (lidocaine   Do.
                               HCl and
                               epinephrine)
                               Injection USP, 2%;
                               0.01 mg/mL and 2%;
                               0.02 mg/mL.
ANDA 084697.................  Isocaine 2%            Do.
                               (mepivacaine HCl
                               and levonordefrin)
                               Injection USP, 2%;
                               0.05 mg/mL.
ANDA 086033.................  Isosorbide Dinitrate  Watson Laboratories,
                               Sublingual Tablets    Inc., Subsidiary of
                               USP, 2.5 mg.          Teva
                                                     Pharmaceuticals
                                                     USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 087504.................  Chloroquine           Teva Pharmaceuticals
                               Phosphate Tablets     USA, Inc., 425
                               USP, EQ 150 mg base.  Privet Rd.,
                                                     Horsham, PA 19044.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
October 26, 2018. Introduction or delivery for introduction into 
interstate commerce of

[[Page 48636]]

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 October 26, 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: September 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-20947 Filed 9-25-18; 8:45 am]
 BILLING CODE 4164-01-P