Document ID: FDA-2019-N-0113-0001
Agency: fda
Document Type: Notice
Title: Facta Farmaceutici S.p.A., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications
Posted Date: 2019-02-05T05:00Z

[Federal Register Volume 84, Number 24 (Tuesday, February 5, 2019)]
[Notices]
[Pages 1745-1746]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-01129]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-0113]

Facta Farmaceutici S.p.A., et al.; Withdrawal of Approval of 23 
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 23 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of March 7, 2019.

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, 
Trang.Tran@fda.hhs.gov.

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 062117...............  Cephalexin for Oral    Facta Farmaceutici
                             Suspension USP,        S.p.A., c/o
                             Equivalent to (EQ)     Interchem Corp., 120
                             100 milligrams (mg)    Route, 17 North,
                             base/milliliter        Paramus, NJ 07652.
                             (mL), EQ 125 mg base/
                             5 mL, and EQ 250 mg
                             base/5 mL.
ANDA 062508...............  Erymax (erythromycin)  Merz North America,
                             Topical Solution       6501 Six Forks Rd.,
                             USP, 2%.               Raleigh, NC 27615.
ANDA 075369...............  Enalapril Maleate      Krka, tovarna
                             Tablets USP, 10 mg     zdravil, d.d., Novo
                             and 20 mg.             mesto, Slovenia, c/o
                                                    KRKA USA, LLC, 4216
                                                    Cravens Point Rd.,
                                                    Wilmington, NC
                                                    28409.
ANDA 075370...............  Enalapril Maleate      Do.
                             Tablets USP, 2.5 mg
                             and 5 mg.

[[Page 1746]]

 
ANDA 077895...............  Ursodiol Capsules      Impax Laboratories,
                             USP, 300 mg.           LLC, 30831 Huntwood
                                                    Ave., Hayward, CA
                                                    94544.
ANDA 078810...............  Oxaliplatin for        Fresenius Kabi
                             Injection, 50 mg/      Oncology Plc., c/o
                             vial and 100 mg/vial.  Fresenius Kabi USA,
                                                    LLC, Three Corporate
                                                    Dr., Lake Zurich, IL
                                                    60047.
ANDA 080420...............  Lidocaine              Lyphomed, Inc., 2045
                             Hydrochloride (HCl)    North Cornell Ave.,
                             Injection USP, 1%,     Melrose Park, IL
                             1.5%, and 2%.          60160.
ANDA 080421...............  Procaine HCl           Do.
                             Injection USP, 1%
                             and 2%.
ANDA 083083...............  Lidocaine HCl          Wyeth-Ayerst
                             Injection USP, 1%      Laboratories, P.O.
                             and 2%.                Box 8299,
                                                    Philadelphia, PA
                                                    19101.
ANDA 083744...............  Lidocaine HCl          Tera Pharmaceuticals,
                             Injection USP, 0.5%,   Inc., 6920 Stanton
                             1%, 1.5%, and 2%.      Ave., Buena Park, CA
                                                    90621.
ANDA 083907...............  Lidocaine HCl With     Do.
                             Epinephrine
                             Injection USP.
ANDA 084571...............  Lidocaine HCl          Knoll
                             Injection, 10 mg/20    Pharmaceuticals, 30
                             mL and 10 mg/50 mL.    North Jefferson Rd.,
                                                    Whippany, NJ 07981.
ANDA 084572...............  Lidocaine HCl          Do.
                             Injection, 20 mg/20
                             mL and 20 mg/50 mL.
ANDA 084720...............  Lidocaine HCl and      Naska Pharmacal Co.,
                             Epinephrine            Inc., Riverview Rd.,
                             Injection USP, 2%;     P.O. Box 898,
                             0.01 mg/mL.            Lincolnton, NC
                                                    28093.
ANDA 084732...............  Lidocaine HCl and      Do.
                             Epinephrine
                             Injection USP, 2%;
                             0.02 mg/mL.
ANDA 084947...............  Alphacaine             Carlisle
                             (lidocaine)            Laboratories, Inc.,
                             Ointment, 5%.          404 Doughty Blvd.,
                                                    Inwood, NY 11696.
ANDA 085037...............  Lidocaine HCl          Akorn, Inc., P.O. Box
                             Injection USP, 1%      1220, Decatur, IL
                             and 2%.                62525.
ANDA 085677...............  Cortisone Acetate      Steris Laboratories,
                             Injectable             Inc., 620 North 51st
                             Suspension USP, 25     Ave., Phoenix, AZ
                             mg/mL and 50 mg/mL.    85043.
ANDA 088051...............  Thalitone              Casper Pharma LLC, 2
                             (chlorthalidone)       Tower Center Blvd.,
                             Tablets USP, 25 mg.    Suite 1101C, East
                                                    Brunswick, NJ 08816.
ANDA 089688...............  Lidocaine HCl Topical  Paco Research, Corp.,
                             Solution USP, 4%.      1705 Oak St.,
                                                    Lakewood, NJ 08701.
ANDA 091212...............  Lansoprazole Delayed-  Krka, tovarna
                             Release Capsules       zdravil, d.d., Novo
                             USP, 15 mg and 30 mg.  mesto, c/o KRKA USA,
                                                    LLC.
ANDA 091377...............  Vancomycin HCl for     Xellia
                             Injection USP, EQ      Pharmaceuticals ApS,
                             500 mg base/vial and   c/o Xellia
                             EQ 1gram (g) base/     Pharmaceuticals USA,
                             vial.                  LLC, 8841 Wadford
                                                    Dr., Raleigh, NC
                                                    27616.
ANDA 206243...............  Vancomycin HCl for     Do.
                             Injection USP, EQ 5
                             g base/vial and EQ
                             10 g base/vial
                             (Pharmacy Bulk
                             Package).
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of March 
7, 2019. 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 March 7, 2019, 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: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-01129 Filed 2-4-19; 8:45 am]
 BILLING CODE 4164-01-P