[Federal Register Volume 84, Number 75 (Thursday, April 18, 2019)]
[Notices]
[Pages 16269-16270]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-07833]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1020]


Aurolife Pharma, LLC, et al.; Withdrawal of Approval of 31 
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 31 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of May 20, 2019.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, 
[email protected].

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.

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            Application No.                               Drug                               Applicant
----------------------------------------------------------------------------------------------------------------
ANDA 070470...........................  Disopyramide Phosphate Capsules USP,      Aurolife Pharma, LLC, 279
                                         Equivalent to (EQ) 100 milligrams (mg)    Princeton Hightstown Rd.,
                                         base.                                     East Windsor, NJ 08520.
ANDA 070471...........................  Disopyramide Phosphate Capsules USP, EQ   Do.
                                         150 mg base.
ANDA 070531...........................  Clofibrate Capsules USP, 500 mg.........  Upsher-Smith Laboratories,
                                                                                   LLC, 301 South Cherokee St.,
                                                                                   Denver, CO 80223.
ANDA 070797...........................  Chlorpheniramine Maleate Extended-        Aurolife Pharma, LLC.
                                         Release Capsules USP, 12 mg.
ANDA 070956...........................  Diazepam Tablets USP, 10 mg.............  Halsey Drug Co., Inc., 1827
                                                                                   Pacific St., Brooklyn, NY
                                                                                   11233.
ANDA 071128...........................  Haloperidol Tablets USP, 0.5 mg.........  Cycle Pharmaceuticals, Ltd., c/
                                                                                   o Mapi USA, Inc., 2343
                                                                                   Alexandria Dr., Suite 100,
                                                                                   Lexington, KY 40504.
ANDA 071129...........................  Haloperidol Tablets USP, 1 mg...........  Do.
ANDA 071133...........................  Haloperidol Tablets USP, 20 mg..........  Do.
ANDA 072394...........................  Fenoprofen Calcium Capsules USP, EQ 200   Aurolife Pharma, LLC.
                                         mg base.
ANDA 072395...........................  Fenoprofen Calcium Capsules USP, EQ 300   Do.
                                         mg base.
ANDA 072396...........................  Fenoprofen Calcium Tablets USP, EQ 600    Do.
                                         mg base.
ANDA 072484...........................  Trazodone Hydrochloride (HCl) Tablets     Do.
                                         USP, 50 mg.
ANDA 074024...........................  Ketoprofen Capsules, 50 mg and 75 mg....  Do.
ANDA 074448...........................  Flurbiprofen Tablets USP, 50 mg and 100   Do.
                                         mg.
ANDA 078300...........................  Pamidronate Disodium for Injection USP,   Mustafa Nevzat Ilac San. A.S.
                                         30 mg/vial and 90 mg/vial.                (MN Pharmaceuticals), c/o
                                                                                   Sagent Pharmaceuticals, Inc.,
                                                                                   1901 North Roselle Rd., suite
                                                                                   450, Schaumburg, IL 60195.
ANDA 080655...........................  Meprobamate Tablets USP, 400 mg.........  Aurolife Pharma, LLC.
ANDA 083234...........................  Glutethimide Tablets, 500 mg............  Upsher-Smith Laboratories,
                                                                                   LLC, 6701 Evenstad Dr. North,
                                                                                   Maple Grove, MN 55369.
ANDA 084156...........................  Pentobarbital Sodium Capsules, 100 mg...  Warner-Lambert Company, 201
                                                                                   Tabor Rd., Morris Plains, NJ
                                                                                   07950.
ANDA 084674...........................  Aminophylline Tables USP, 100 mg........  Halsey Drug Co., Inc.
ANDA 085628...........................  Sulfisoxazole Tablets USP, 500 mg.......  Aurolife Pharma, LLC.
ANDA 085813...........................  Prednisone Tablets USP, 20 mg...........  Do.
ANDA 085844...........................  Sulfamethoxazole Tablets USP, 500 mg....  Do.
ANDA 085925...........................  Amitriptyline HCl Tablets USP, 50 mg....  Halsey Drug Co., Inc.
ANDA 085926...........................  Amitriptyline HCl Tablets USP, 75 mg....  Do.
ANDA 085927...........................  Amitriptyline HCl Tablets USP, 100 mg...  Do.
ANDA 089057...........................  Cyproheptadine HCl Tablets USP, 4 mg....  Do.
ANDA 089117...........................  Hydroxyzine HCl Tablets USP, 25 mg......  Do.
ANDA 089894...........................  Quinidine Gluconate Extended-Release      Aurolife Pharma, LLC.
                                         Tablets USP, 324 mg.
ANDA 089983...........................  Prednisone Tablets USP, 10 mg...........  Do.

[[Page 16270]]

 
ANDA 089984...........................  Prednisone Tablets USP, 50 mg...........  Do.
ANDA 208991...........................  Piroxicam Capsules USP, 10 mg and 20 mg.  Breckenridge Pharmaceutical,
                                                                                   Inc., 15 Massirio Dr., suite
                                                                                   201, Berlin, CT 06037.
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    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of May 
20, 2019. Approval of each entire application is withdrawn, including 
any strengths or products missing from the table. 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 May 20, 
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: April 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-07833 Filed 4-17-19; 8:45 am]
BILLING CODE 4164-01-P


