[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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of June 24, 2019.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,
[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
[[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.
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Application No. Drug Applicant
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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.
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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