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Facta Farmaceutici S.p.A., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications

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Food and Drug Administration, HHS.




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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.


Approval is withdrawn as of March 7, 2019.

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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,

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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 § 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 § 314.150(c) is without prejudice to refiling.

Application No.DrugApplicant
ANDA 062117Cephalexin for Oral Suspension USP, Equivalent to (EQ) 100 milligrams (mg) base/milliliter (mL), EQ 125 mg base/5 mL, and EQ 250 mg base/5 mLFacta Farmaceutici S.p.A., c/o Interchem Corp., 120 Route, 17 North, Paramus, NJ 07652.
ANDA 062508Erymax (erythromycin) Topical Solution USP, 2%Merz North America, 6501 Six Forks Rd., Raleigh, NC 27615.
ANDA 075369Enalapril Maleate Tablets USP, 10 mg and 20 mgKrka, tovarna zdravil, d.d., Novo mesto, Slovenia, c/o KRKA USA, LLC, 4216 Cravens Point Rd., Wilmington, NC 28409.
ANDA 075370Enalapril Maleate Tablets USP, 2.5 mg and 5 mgDo.
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ANDA 077895Ursodiol Capsules USP, 300 mgImpax Laboratories, LLC, 30831 Huntwood Ave., Hayward, CA 94544.
ANDA 078810Oxaliplatin for Injection, 50 mg/vial and 100 mg/vialFresenius Kabi Oncology Plc., c/o Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
ANDA 080420Lidocaine Hydrochloride (HCl) Injection USP, 1%, 1.5%, and 2%Lyphomed, Inc., 2045 North Cornell Ave., Melrose Park, IL 60160.
ANDA 080421Procaine HCl Injection USP, 1% and 2%Do.
ANDA 083083Lidocaine HCl Injection USP, 1% and 2%Wyeth-Ayerst Laboratories, P.O. Box 8299, Philadelphia, PA 19101.
ANDA 083744Lidocaine HCl Injection USP, 0.5%, 1%, 1.5%, and 2%Tera Pharmaceuticals, Inc., 6920 Stanton Ave., Buena Park, CA 90621.
ANDA 083907Lidocaine HCl With Epinephrine Injection USPDo.
ANDA 084571Lidocaine HCl Injection, 10 mg/20 mL and 10 mg/50 mLKnoll Pharmaceuticals, 30 North Jefferson Rd., Whippany, NJ 07981.
ANDA 084572Lidocaine HCl Injection, 20 mg/20 mL and 20 mg/50 mLDo.
ANDA 084720Lidocaine HCl and Epinephrine Injection USP, 2%; 0.01 mg/mLNaska Pharmacal Co., Inc., Riverview Rd., P.O. Box 898, Lincolnton, NC 28093.
ANDA 084732Lidocaine HCl and Epinephrine Injection USP, 2%; 0.02 mg/mLDo.
ANDA 084947Alphacaine (lidocaine) Ointment, 5%Carlisle Laboratories, Inc., 404 Doughty Blvd., Inwood, NY 11696.
ANDA 085037Lidocaine HCl Injection USP, 1% and 2%Akorn, Inc., P.O. Box 1220, Decatur, IL 62525.
ANDA 085677Cortisone Acetate Injectable Suspension USP, 25 mg/mL and 50 mg/mLSteris Laboratories, Inc., 620 North 51st Ave., Phoenix, AZ 85043.
ANDA 088051Thalitone (chlorthalidone) Tablets USP, 25 mgCasper Pharma LLC, 2 Tower Center Blvd., Suite 1101C, East Brunswick, NJ 08816.
ANDA 089688Lidocaine HCl Topical Solution USP, 4%Paco Research, Corp., 1705 Oak St., Lakewood, NJ 08701.
ANDA 091212Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mgKrka, tovarna zdravil, d.d., Novo mesto, c/o KRKA USA, LLC.
ANDA 091377Vancomycin HCl for Injection USP, EQ 500 mg base/vial and EQ 1gram (g) base/vialXellia Pharmaceuticals ApS, c/o Xellia Pharmaceuticals USA, LLC, 8841 Wadford Dr., Raleigh, NC 27616.
ANDA 206243Vancomycin HCl for Injection USP, EQ 5 g base/vial and EQ 10 g base/vial (Pharmacy Bulk Package)Do.

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.

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Dated: January 16, 2019.

Leslie Kux,

Associate Commissioner for Policy.

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[FR Doc. 2019-01129 Filed 2-4-19; 8:45 am]