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Notice

Bedford Laboratories, et al.; Withdrawal of Approval of 24 Abbreviated New Drug Applications

A Notice by the Food and Drug Administration on 05/23/2019

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Published Document: 2019-10809 (84 FR 23795)

This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Department of Health and Human Services
Food and Drug Administration
  1. [Docket No. FDA-2019-N-1524]

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.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Approval is withdrawn as of June 24, 2019.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, .

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 § 314.150(c) (21 CFR 314.150(c)). The applicants have also, by their requests, waived their ( printed page 23796) 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 040524 Promethazine Hydrochloride (HCl) Injection USP, 25 milligrams (mg)/milliliter (mL) and 50 mg/mL Bedford Laboratories, 300 Northfield Rd., Bedford, OH 44146.
ANDA 070857 Trazodone HCl Tablets USP, 50 mg Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 070987 Diazepam Tablets USP, 2 mg Halsey Drug Co., Inc., 1827 Pacific St., Brooklyn, NY 11233.
ANDA 070996 Diazepam Tablets USP, 5 mg   Do.
ANDA 071717 Flurazepam HCl Capsules USP, 15 mg and 30 mg Aurolife Pharma, LLC, 279 Princeton Hightstown Rd., East Windsor, NJ 08520.
ANDA 071751 Methyldopa Tablets USP, 125 mg Halsey Drug Co., Inc.
ANDA 071752 Methyldopa Tablets USP, 250 mg   Do.
ANDA 077190 Milrinone Lactate Injection, EQ 1 mg base/mL Gland Pharma, Ltd., c/o INC Research, LLC, 4800 Falls of Neuse Rd., Suite 600, Raleigh, NC 27609.
ANDA 077703 Pamidronate Disodium for Injection USP, 30 mg/vial and 90 mg/vial Sun Pharma Global FZE, c/o Sun Pharmaceutical Industries, Inc., 270 Prospect Plains Rd., Cranbury, NJ 08512.
ANDA 080300 Prednisone Tablets USP, 5 mg Halsey Drug Co., Inc.
ANDA 080961 Chlorpheniramine Maleate Tablets USP, 4 mg Aurolife Pharma, LLC.
ANDA 083453 Niacin Tablets USP, 500 mg Halsey Drug Co., Inc.
ANDA 083629 Kloromin (chlorpheniramine maleate) Tablets USP, 4 mg   Do.
ANDA 083930 Dextroamphetamine Sulfate Tablets USP, 10 mg   Do.
ANDA 084676 Secobarbital Sodium Capsules USP, 100 mg   Do.
ANDA 085088 Hydralazine HCl Tablets USP, 50 mg Upsher-Smith Laboratories, LLC, 6701 Evenstad Dr., Maple Grove, MN 55369.
ANDA 085219 Hydrochlorothiazide Tablets, 50 mg Aurolife Pharma, LLC.
ANDA 085923 Amitriptyline HCl Tablets USP, 10 mg Halsey Drug Co., Inc.
ANDA 087279 Butalbital, Aspirin, and Caffeine Tablets Sandoz, Inc., 227-15 North Conduit Ave., Laurelton, NY 11413.
ANDA 088116 Myfed (pseudoephedrine HCl and triprolidine HCl) Syrup, 30 mg/5 mL and 1.25 mg/5 mL USL Pharma, LLC, 301 South Cherokee St., Denver, CO 80223.
ANDA 088725 Chlorpropamide Tablets USP, 100 mg Aurolife Pharma, LLC.
ANDA 089130 Hydralazine HCl Tablets USP, 25 mg Halsey Drug Co., Inc.
ANDA 089178 Hydralazine HCl Tablets USP, 100 mg     Do.
ANDA 201484 Levofloxacin Tablets, 250 mg, 500 mg, and 750 mg Watson Laboratories, Inc., Subsidiary of 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

Published Document: 2019-10809 (84 FR 23795)