# Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications
**AGENCY:**
Food and Drug Administration, HHS.
**ACTION:**
Notice.
**SUMMARY:**
The Food and Drug Administration (FDA or Agency) is withdrawing approval of 27 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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of September 7, 2018.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 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. | Drug | Applicant |
| --- | --- | --- |
| ANDA 061467 | Pyocidin-Otic (hydrocortisone and polymyxin B sulfate) Otic Solution, 5 milligrams (mg)/10,000 units per milliliter (mL) | Fougera Pharmaceuticals, Inc., 60 Baylis Rd., P.O. Box 2006, Melville, NY 11747. |
| ANDA 061653 | Tetrex (tetracycline phosphate complex) Capsules, Equivalent to (EQ) 100 mg Hydrochloride (HCl), EQ 250 mg HCl and EQ 500 mg HCl | Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 08543. |
| ANDA 061658 | Bristacycline (tetracycline HCl) Capsules, 250 mg and 500 mg | Do. |
| ANDA 061711 | Penicillin V Potassium Tablets | Do. |
| ANDA 061721 | Ampicillin Capsules, 250 mg and 500 mg | Do. |
| ANDA 061726 | Azotrex (phenazopyridine HCl, sulfamethizole and tetracycline phosphate complex) Capsules, 50 mg/250 mg/125 mg | Do. |
| ANDA 061790 | Hetacillin Potassium | Do. |
| ANDA 061887 | Bristamycin (erythromycin stearate) Tablets, EQ 250 mg base | Do. |
| ANDA 061888 | Bristacycline (tetracycline HCl) Capsules, 250 mg and 500 mg | Do. |
| ANDA 061889 | Tetrex (tetracycline phosphate complex) Capsules, EQ 250 mg HCl and EQ 500 mg HCl | Do. |
| ANDA 061890 | Azotrex (phenazopyridine HCl, sulfamethizole, and tetracycline) Capsules, 50 mg/250 mg/125 mg | Do. |
| ANDA 061891 | Tetrex-S (tetracycline) Syrup, 125 mg/5 mL | Do. |
| ANDA 061975 | Cephradine Powder for Injection | Do. |
| ANDA 062168 | Cephradine Tablets | Do. |
| ANDA 062259 | Amphotericin B for Use in Parenteral Products | Do. |
| ANDA 062543 | Mycolog (nystatin, neomycin sulfate, gramicidin, and triamcinolone acetonide) Ointment | Do. |
| ANDA 071793 | Foamcoat (aluminum hydroxide; magnesium trisilicate) Chewable Tablets, 80 mg/20 mg (OTC) | Guardian Drug Co., 2 Charles Court, Dayton, NJ 08810. |
| ANDA 072035 | Nuprin (ibuprofen) Tablets, 200 mg | Bristol-Myers Squibb Co. |
| ANDA 072036 | Nuprin (ibuprofen) Tablets, 200 mg | Do. |
| ANDA 074911 | Phrenilin with Caffeine and Codeine (acetaminophen, butalbital, caffeine, and codeine phosphate) Capsules, 325 mg/50 mg/40 mg/30 mg | Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. |
| ANDA 074944 | Atracurium Besylate Injection, 10 mg/mL | Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. |
| ANDA 075206 | Cytosar-U (cytarabine) for Injection USP, 100 mg/vial, 500 mg/vial, 1 gram (g)/vial, and 2 g/vial | Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044. |
| ANDA 077337 | Rosiglitazone Maleate and Metformin HCl Tablets, EQ 1 mg base/500 mg, EQ 2 mg base/500 mg, EQ 4 mg base/500 mg, EQ 2 mg base/1 g, and EQ 4 mg base/1 g | Do. |
| ANDA 077930 | Meloxicam Tablets, 7.5 mg and 15 mg | Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, CA 94544. |
| ANDA 080658 | Procaine HCl Injection, 1% and 2% | Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. |
| ANDA 083128 | Hydrocortisone Acetate Injectable Suspension, 25 mg/mL | Do. |
| ANDA 090181 | Ifosfamide for Injection, 1 g/20 mL and 3 g/60 mL | Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. |
Therefore, approval of the applications listed in the table, and all amendments and supplements thereto, is hereby withdrawn as of September 7, 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 September 7, 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: August 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.