83 FR 56086 - Tedor Pharma, Inc., et al.; Withdrawal of Approval of 10 Abbreviated New Drug Applications

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 218 (November 9, 2018)

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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 218 (Friday, November 9, 2018)]
[Notices]
[Pages 56086-56087]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-24605]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-4099]


Tedor Pharma, Inc., et al.; Withdrawal of Approval of 10 
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 10 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of December 10, 2018.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.

[[Page 56087]]



------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 040747.................  Benzphetamine         Tedor Pharma, Inc.,
                               Hydrochloride (HCl)   400 Highland
                               Tablets, 25           Corporate Dr.,
                               milligrams (mg) and   Cumberland, RI
                               50 mg.                02864.
ANDA 062356.................  Gentamicin Sulfate    Fresenius Kabi USA,
                               Injection USP,        LLC, Three
                               Equivalent to (EQ)    Corporate Dr., Lake
                               10 mg base/           Zurich, IL 60047.
                               milliliter (mL) and
                               EQ 40 mg base/mL.
ANDA 074097.................  Isoflurane USP,       Hospira, Inc., 275
                               99.9%.                North Field Dr.,
                                                     Bldg. H1, Lake
                                                     Forest, IL 60045.
ANDA 076484.................  Ciprofloxacin         Fresenius Kabi USA,
                               Injection USP, 200    LLC.
                               mg/20 mL and 400 mg/
                               40 mL.
ANDA 080504.................  Epinephrine and       Belmora LLC, 2231
                               Lidocaine HCl         Crystal Dr., #1000,
                               Injection, 0.01 mg/   Arlington, VA
                               mL; 2% and 0.02 mg/   22202.
                               mL; 2%.
                              Lidocaine HCl
                               Injection, 2%..
ANDA 083559.................  Mepivacaine HCl       Do.
                               Injection, 3%.
ANDA 084315.................  Dexamethasone         Watson Laboratories,
                               Acetate Injectable    Inc., Subsidiary of
                               Suspension USP, EQ    Teva
                               8 mg base/mL.         Pharmaceuticals
                                                     USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 084850.................  Levonordefrin and     Belmora LLC.
                               Mepivacaine HCl
                               Injection, 2%; 0.05
                               mg/mL.
ANDA 086389.................  Lidocaine HCl         International
                               Viscous Oral          Medication Systems,
                               Topical Solution      Ltd., 1886 Santa
                               USP, 2%.              Anita Ave., South
                                                     El Monte, CA 91733.
ANDA 087863.................  Choledyl SA           Warner Chilcott Co.,
                               (oxtriphylline)       LLC, Subsidiary of
                               Extended-Release      Teva
                               Tablets USP, 400 mg.  Pharmaceuticals
                                                     USA, Inc., 425
                                                     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 
December 10, 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 December 10, 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: November 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24605 Filed 11-8-18; 8:45 am]
 BILLING CODE 4164-01-P