[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39102-39103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16985]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2485]


Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 
27 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 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requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of September 7, 2018.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, 
<a href="/cdn-cgi/l/email-protection#742006151a135a2006151a341210155a1c1c075a131b02"><span class="__cf_email__" data-cfemail="346046555a531a6046555a745250551a5c5c471a535b42">[email protected]</span></a>.

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 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 061467...................  Pyocidin-Otic           Fougera
                                 (hydrocortisone and     Pharmaceuticals
                                 polymyxin B sulfate)    , Inc., 60
                                 Otic Solution, 5        Baylis Rd.,
                                 milligrams (mg)/        P.O. Box 2006,
                                 10,000 units per        Melville, NY
                                 milliliter (mL).        11747.
ANDA 061653...................  Tetrex (tetracycline    Bristol-Myers
                                 phosphate complex)      Squibb Co.,
                                 Capsules, Equivalent    P.O. Box 4000,
                                 to (EQ) 100 mg          Princeton, NJ
                                 Hydrochloride (HCl),    08543.
                                 EQ 250 mg HCl and EQ
                                 500 mg HCl.
ANDA 061658...................  Bristacycline           Do.
                                 (tetracycline HCl)
                                 Capsules, 250 mg and
                                 500 mg.
ANDA 061711...................  Penicillin V Potassium  Do.
                                 Tablets.
ANDA 061721...................  Ampicillin Capsules,    Do.
                                 250 mg and 500 mg.
ANDA 061726...................  Azotrex                 Do.
                                 (phenazopyridine HCl,
                                 sulfamethizole and
                                 tetracycline
                                 phosphate complex)
                                 Capsules, 50 mg/250
                                 mg/125 mg.
ANDA 061790...................  Hetacillin Potassium..  Do.
ANDA 061887...................  Bristamycin             Do.
                                 (erythromycin
                                 stearate) Tablets, EQ
                                 250 mg base.
ANDA 061888...................  Bristacycline           Do.
                                 (tetracycline HCl)
                                 Capsules, 250 mg and
                                 500 mg.
ANDA 061889...................  Tetrex (tetracycline    Do.
                                 phosphate complex)
                                 Capsules, EQ 250 mg
                                 HCl and EQ 500 mg HCl.
ANDA 061890...................  Azotrex                 Do.
                                 (phenazopyridine HCl,
                                 sulfamethizole, and
                                 tetracycline)
                                 Capsules, 50 mg/250
                                 mg/125 mg.
ANDA 061891...................  Tetrex-S                Do.
                                 (tetracycline) Syrup,
                                 125 mg/5 mL.
ANDA 061975...................  Cephradine Powder for   Do.
                                 Injection.
ANDA 062168...................  Cephradine Tablets....  Do.
ANDA 062259...................  Amphotericin B for Use  Do.
                                 in Parenteral
                                 Products.
ANDA 062543...................  Mycolog (nystatin,      Do.
                                 neomycin sulfate,
                                 gramicidin, and
                                 triamcinolone
                                 acetonide) Ointment.
ANDA 071793...................  Foamcoat (aluminum      Guardian Drug
                                 hydroxide; magnesium    Co., 2 Charles
                                 trisilicate) Chewable   Court, Dayton,
                                 Tablets, 80 mg/20 mg    NJ 08810.
                                 (OTC).
ANDA 072035...................  Nuprin (ibuprofen)      Bristol-Myers
                                 Tablets, 200 mg.        Squibb Co.
ANDA 072036...................  Nuprin (ibuprofen)      Do.
                                 Tablets, 200 mg.
ANDA 074911...................  Phrenilin with          Valeant
                                 Caffeine and Codeine    Pharmaceuticals
                                 (acetaminophen,         North America,
                                 butalbital, caffeine,   LLC, 400
                                 and codeine             Somerset
                                 phosphate) Capsules,    Corporate
                                 325 mg/50 mg/40 mg/30   Blvd.,
                                 mg.                     Bridgewater, NJ
                                                         08807.
ANDA 074944...................  Atracurium Besylate     Watson
                                 Injection, 10 mg/mL.    Laboratories,
                                                         Inc.,
                                                         Subsidiary of
                                                         Teva
                                                         Pharmaceuticals
                                                         USA, Inc., 425
                                                         Privet Rd.,
                                                         Horsham, PA
                                                         19044.
ANDA 075206...................  Cytosar-U (cytarabine)  Teva
                                 for Injection USP,      Pharmaceuticals
                                 100 mg/vial, 500 mg/    USA, Inc., 425
                                 vial, 1 gram (g)/       Privet Rd.,
                                 vial, and 2 g/vial.     Horsham, PA
                                                         19044.
ANDA 077337...................  Rosiglitazone Maleate   Do.
                                 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.
ANDA 077930...................  Meloxicam Tablets, 7.5  Impax
                                 mg and 15 mg.           Laboratories,
                                                         Inc., 30831
                                                         Huntwood Ave.,
                                                         Hayward, CA
                                                         94544.
ANDA 080658...................  Procaine HCl            Watson
                                 Injection, 1% and 2%.   Laboratories,
                                                         Inc.,
                                                         Subsidiary of
                                                         Teva
                                                         Pharmaceuticals
                                                         USA, Inc.
ANDA 083128...................  Hydrocortisone Acetate  Do.
                                 Injectable
                                 Suspension, 25 mg/mL.
ANDA 090181...................  Ifosfamide for          Fresenius Kabi
                                 Injection, 1 g/20 mL    USA, LLC, Three
                                 and 3 g/60 mL.          Corporate Dr.,
                                                         Lake Zurich, IL
                                                         60047.
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[[Page 39103]]

    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.
[FR Doc. 2018-16985 Filed 8-7-18; 8:45 am]
BILLING CODE 4164-01-P


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