[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Pages 40070-40071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17226]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2876]


Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 
20 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 20 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requested that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of September 12, 2018.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 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.

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       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 060133.................  Chloramphenicol       Fougera
                               Ophthalmic            Pharmaceuticals,
                               Ointment, 1%.         Inc., 60 Baylis
                                                     Rd., P.O. Box 2006,
                                                     Melville, NY 11747.
ANDA 060572.................  Mycolog II (nystatin  Mylan
                               and triamcinolone     Pharmaceuticals,
                               acetonide) Ointment   Inc., 781 Chestnut
                               USP, 100,000 units/   Ridge Rd., P.O. Box
                               gram (g) and 0.1%.    4310, Morgantown,
                                                     WV 26504.
ANDA 061107.................  Hydrocortisone        Fougera
                               Acetate and           Pharmaceuticals,
                               Neomycin Sulfate      Inc..
                               Ointment,
                               0.5%[hairsp]/
                               [hairsp]0.5% and
                               1.5%[hairsp]/
                               [hairsp]0.5%.
ANDA 061988.................  Polycillin            Bristol-Myers Squibb
                               (ampicillin)          Co., P.O. Box 4000,
                               Capsules, 250         Princeton, NJ
                               milligrams (mg) and   08543.
                               500 mg.
ANDA 072097.................  Cap-Profen            L. Perrigo Co., 515
                               (ibuprofen) Tablets   Eastern Ave.,
                               USP, 200 mg (White).  Allegan, MI 49010.
ANDA 072098.................  Ibuprofen Tablets,     Do.
                               200 mg (Brown).
ANDA 074334.................  Vecuronium Bromide    Watson Laboratories,
                               for Injection, 10     Inc., Subsidiary of
                               mg/vial and 20 mg/    Teva
                               vial.                 Pharmaceuticals
                                                     USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 074874.................  Pentoxifylline        Pliva, Inc.,
                               Extended-Release      Subsidiary of Teva
                               Tablets, 400 mg.      Pharmaceuticals
                                                     USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.

[[Page 40071]]

 
ANDA 074945.................  Atracurium Besylate   Watson Laboratories,
                               Injection, 10 mg/     Inc., Subsidiary of
                               milliliter (mL).      Teva
                                                     Pharmaceuticals
                                                     USA, Inc.
ANDA 077251.................  Finasteride Tablets   Gedeon Richter Plc.,
                               USP, 5 mg.            c/o Gedeon Richter
                                                     USA, Inc., 119
                                                     Cherry Hill Rd.,
                                                     Suite 325,
                                                     Parsippany, NJ
                                                     07054.
ANDA 077983.................  Gemcitabine for       Teva Pharmaceuticals
                               Injection USP,        USA, Inc., 425
                               Equivalent to (EQ)    Privet Rd.,
                               200 mg base/vial      Horsham, PA 19044.
                               and EQ 1 g/vial.
ANDA 080425.................  Texacort              Mission Pharmacal
                               (hydrocortisone)      Co., 10999 IH 10
                               Topical Solution,     West, Suite 1000,
                               1%.                   San Antonio, TX
                                                     78230.
ANDA 083242.................  Amen                  Valeant
                               (medroxyprogesteron   Pharmaceuticals
                               e acetate) Tablets,   North America, LLC,
                               10 mg.                400 Somerset
                                                     Corporate Blvd.,
                                                     Bridgewater, NJ
                                                     08807.
ANDA 085455.................  Dexamethasone         Watson Laboratories,
                               Tablets USP, 0.25     Inc., Subsidiary of
                               mg.                   Teva
                                                     Pharmaceuticals
                                                     USA, Inc..
ANDA 086308.................  Homapin-10            Mission Pharmacal
                               (homatropine          Co.
                               methylbromide)
                               Tablets USP, 10 mg.
ANDA 086309.................  Homapin-5              Do.
                               (homatropine
                               methylbromide)
                               Tablets USP, 5 mg.
ANDA 086310.................  Equipin (homatropine   Do.
                               methylbromide)
                               Chewable Tablets, 3
                               mg.
ANDA 086711.................  Beta-2 (isoetharine   Nephron
                               hydrochloride         Pharmaceuticals,
                               (HCl)) Inhalation     Corp., 4500 12th
                               Solution, 1%.         St. Extension, West
                                                     Columbia, SC 20172.
ANDA 087438.................  Folicet (folic acid)  Mission Pharmacal
                               Tablets USP, 1 mg.    Co.
ANDA 087939.................  Trimethobenzamide     Watson Laboratories,
                               HCl Injection, 100    Inc., Subsidiary of
                               mg/mL.                Teva
                                                     Pharmaceuticals
                                                     USA, Inc.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of 
September 12, 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 12, 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 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17226 Filed 8-10-18; 8:45 am]
 BILLING CODE 4164-01-P


