Document ID: FDA-2019-N-1524-0001
Agency: fda
Document Type: Notice
Title: Bedford Laboratories, et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications
Posted Date: 2019-05-23T04:00Z

[Federal Register Volume 84, Number 100 (Thursday, May 23, 2019)]
[Notices]
[Pages 23795-23796]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10809]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-1524]

Bedford Laboratories, et al.; Withdrawal of Approval of 24 
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 24 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approval of the applications be withdrawn.

DATES: Approval is withdrawn as of June 24, 2019.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, 
Trang.Tran@fda.hhs.gov.

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

[[Page 23796]]

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 040524.................  Promethazine          Bedford
                               Hydrochloride (HCl)   Laboratories, 300
                               Injection USP, 25     Northfield Rd.,
                               milligrams (mg)/      Bedford, OH 44146.
                               milliliter (mL) and
                               50 mg/mL.
ANDA 070857.................  Trazodone HCl         Watson Laboratories,
                               Tablets USP, 50 mg.   Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 070987.................  Diazepam Tablets      Halsey Drug Co.,
                               USP, 2 mg.            Inc., 1827 Pacific
                                                     St., Brooklyn, NY
                                                     11233.
ANDA 070996.................  Diazepam Tablets       Do.
                               USP, 5 mg.
ANDA 071717.................  Flurazepam HCl        Aurolife Pharma,
                               Capsules USP, 15 mg   LLC, 279 Princeton
                               and 30 mg.            Hightstown Rd.,
                                                     East Windsor, NJ
                                                     08520.
ANDA 071751.................  Methyldopa Tablets    Halsey Drug Co.,
                               USP, 125 mg.          Inc.
ANDA 071752.................  Methyldopa Tablets     Do.
                               USP, 250 mg.
ANDA 077190.................  Milrinone Lactate     Gland Pharma, Ltd.,
                               Injection, EQ 1 mg    c/o INC Research,
                               base/mL.              LLC, 4800 Falls of
                                                     Neuse Rd., Suite
                                                     600, Raleigh, NC
                                                     27609.
ANDA 077703.................  Pamidronate Disodium  Sun Pharma Global
                               for Injection USP,    FZE, c/o Sun
                               30 mg/vial and 90     Pharmaceutical
                               mg/vial.              Industries, Inc.,
                                                     270 Prospect Plains
                                                     Rd., Cranbury, NJ
                                                     08512.
ANDA 080300.................  Prednisone Tablets    Halsey Drug Co.,
                               USP, 5 mg.            Inc.
ANDA 080961.................  Chlorpheniramine      Aurolife Pharma,
                               Maleate Tablets       LLC.
                               USP, 4 mg.
ANDA 083453.................  Niacin Tablets USP,   Halsey Drug Co.,
                               500 mg.               Inc.
ANDA 083629.................  Kloromin               Do.
                               (chlorpheniramine
                               maleate) Tablets
                               USP, 4 mg.
ANDA 083930.................  Dextroamphetamine      Do.
                               Sulfate Tablets
                               USP, 10 mg.
ANDA 084676.................  Secobarbital Sodium    Do.
                               Capsules USP, 100
                               mg.
ANDA 085088.................  Hydralazine HCl       Upsher-Smith
                               Tablets USP, 50 mg.   Laboratories, LLC,
                                                     6701 Evenstad Dr.,
                                                     Maple Grove, MN
                                                     55369.
ANDA 085219.................  Hydrochlorothiazide   Aurolife Pharma,
                               Tablets, 50 mg.       LLC.
ANDA 085923.................  Amitriptyline HCl     Halsey Drug Co.,
                               Tablets USP, 10 mg.   Inc.
ANDA 087279.................  Butalbital, Aspirin,  Sandoz, Inc., 227-15
                               and Caffeine          North Conduit Ave.,
                               Tablets.              Laurelton, NY
                                                     11413.
ANDA 088116.................  Myfed                 USL Pharma, LLC, 301
                               (pseudoephedrine      South Cherokee St.,
                               HCl and               Denver, CO 80223.
                               triprolidine HCl)
                               Syrup, 30 mg/5 mL
                               and 1.25 mg/5 mL.
ANDA 088725.................  Chlorpropamide        Aurolife Pharma,
                               Tablets USP, 100 mg.  LLC.
ANDA 089130.................  Hydralazine HCl       Halsey Drug Co.,
                               Tablets USP, 25 mg.   Inc.
ANDA 089178.................  Hydralazine HCl        Do.
                               Tablets USP, 100 mg.
ANDA 201484.................  Levofloxacin          Watson Laboratories,
                               Tablets, 250 mg,      Inc., Subsidiary of
                               500 mg, and 750 mg.   Teva
                                                     Pharmaceuticals
                                                     USA, Inc.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in the table, and 
all amendments and supplements thereto, is hereby withdrawn as of June 
24, 2019. Approval of each entire application is withdrawn, including 
any strengths or products inadvertently 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 June 24, 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: May 20, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10809 Filed 5-22-19; 8:45 am]
 BILLING CODE 4164-01-P