83 FR 19787 - Ferndale Laboratories, Inc., et al.; Withdrawal of Approval of Nine Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 87 (May 4, 2018)

The Food and Drug Administration (FDA or Agency) is withdrawing approval of nine abbreviated new drug applications (ANDAs) 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 87 (Friday, May 4, 2018)]
[Notices]
[Pages 19787-19788]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-09534]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-1564]


Ferndale Laboratories, Inc., et al.; Withdrawal of Approval of 
Nine 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 nine abbreviated new drug applications (ANDAs) 
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requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of June 4, 2018.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

[[Page 19788]]

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 040259.....................  Hydrocortisone      Ferndale
                                   Acetate Cream       Laboratories,
                                   USP, 2.5%.          Inc., 780 West
                                                       Eight Mile Rd.,
                                                       Ferndale, MI
                                                       48220.
ANDA 040457.....................  Pyridostigmine      Impax
                                   Bromide Tablets     Laboratories,
                                   USP, 60             Inc., 30831
                                   milligrams (mg).    Huntwood Ave.,
                                                       Hayward, CA
                                                       94544.
ANDA 061806.....................  Cloxapen            GlaxoSmithKline,
                                   (cloxacillin        LLC, 5 Crescent
                                   sodium) Capsules,   Dr.,
                                   Equivalent to       Philadelphia, PA
                                   (EQ) 250 mg base    19112.
                                   and EQ 500 mg
                                   base.
ANDA 065453.....................  Vancomycin          Fresenius Kabi
                                   Hydrochloride       USA, LLC, Three
                                   (HCl) Capsules      Corporate Dr.,
                                   USP, EQ 125 mg      Lake Zurich, IL
                                   base and EQ 250     60047.
                                   mg base.
ANDA 075836.....................  Calcitriol          Do.
                                   Injection, 1
                                   microgram (mcg)/
                                   milliliter (mL)
                                   and 2 mcg/mL.
ANDA 075916.....................  Rimantadine HCl     Impax
                                   Tablets USP, 100    Laboratories,
                                   mg.                 Inc.
ANDA 076731.....................  Glyburide and       Do.
                                   Metformin HCl
                                   Tablets USP, 1.25
                                   mg/250 mg, 2.5 mg/
                                   500 mg, and 5 mg/
                                   500 mg.
ANDA 076889.....................  Fluconazole in      Mylan
                                   Sodium Chloride     Laboratories,
                                   0.9% Injection,     Ltd., c/o Mylan
                                   200 mg/100 mL and   Pharmaceuticals,
                                   400 mg/200 mL.      Inc., 781
                                                       Chestnut Ridge
                                                       Rd., P.O. Box
                                                       4310, Morgantown,
                                                       WV 26504.
ANDA 088572.....................  Pediatric LTA Kit   Abbott
                                   (lidocaine HCl)     Laboratories, One
                                   Solution, 2%.       Abbott Park Rd.,
                                                       Abbott Park, IL
                                                       60064.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of June 
4, 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 June 4, 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: May 1, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-09534 Filed 5-3-18; 8:45 am]
 BILLING CODE 4164-01-P