[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49102-49103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21199]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-3569]
GlaxoSmithKline, LLC, 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approval of the applications be withdrawn.
DATES: Approval is withdrawn as of October 29, 2018.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 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
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ANDA 061336............ Bactocill (oxacillin GlaxoSmithKline, LLC,
sodium) Capsules, Five Moore Dr., P.O.
Equivalent to (EQ) 250 Box 13398, Research
milligrams (mg) base Triangle Park, NC
and EQ 500 mg base. 27709.
ANDA 061773............ Kefzol (cefazolin) for ACS Dobfar S.p.A., c/o
Injection USP, EQ 250 Interchem Corp., 120
mg base/vial, EQ 500 Rte. 17 North,
mg base/vial, EQ 1 Paramus, NJ 07652.
gram (g) base/vial, EQ
10 g base/vial, and EQ
20 g base/vial.
ANDA 062615............ Nystatin Vaginal Odyssey
Inserts USP, 100,000 Pharmaceuticals,
units. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 063304............ Clindamycin Phosphate Wockhardt Bio AG, c/o
Topical Solution USP, Morton Grove
EQ 1% base. Pharmaceuticals,
Inc., 6451 Main St.,
Morton Grove, IL
60053.
ANDA 065001............ Cefuroxime for Fresenius Kabi USA,
Injection USP, EQ LLC, Three Corporate
750mg base/vial and EQ Dr., Lake Zurich, IL
1.5 g base/vial. 60047.
ANDA 065002............ Cefuroxime for Do.
Injection USP, EQ 7.5
g base/vial (Pharmacy
Bulk Package).
ANDA 070736............ Ibuprofen Tablets USP, Aurolife Pharma, LLC,
300 mg, 400 mg, and 279 Princeton
600 mg. Hightstown Rd., East
Windsor, NJ 08520.
ANDA 071202............ Sensorcaine--MPF Spinal Fresenius Kabi USA,
(bupivacaine LLC.
hydrochloride (HCl))
in Dextrose Injection
8.25% USP, 0.75%.
ANDA 071846............ Nitroglycerin in Hospira, Inc., 275
Dextrose 5% Injection, North Field Dr.,
10 mg/100 milliliter Bldg. H1, Lake
(mL). Forest, IL 60045.
ANDA 071847............ Nitroglycerin in Do.
Dextrose 5% Injection,
20 mg/100 mL.
ANDA 071848............ Nitroglycerin in Do.
Dextrose 5% Injection,
40 mg/100 mL.
ANDA 072629............ Albuterol Tablets USP, Watson Laboratories,
EQ 2 mg base. Inc., Subsidiary of
Teva Pharmaceuticals
USA Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 074991............ Loperamide HCl Oral Duramed
Solution, 1 mg/5 mL. Pharmaceuticals,
Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc., 425 Privet
Rd., Horsham, PA
19044.
[[Page 49103]]
ANDA 077312............ Fentanyl Citrate Troche/ Par Pharmaceutical,
Lozenge, EQ 0.2 mg Inc., One Ram Ridge
base, EQ 0.4 mg base, Rd., Chestnut Ridge,
EQ 0.6 mg base, EQ 0.8 NY 10977.
mg base, EQ 1.2 mg,
and EQ 1.6 mg base.
ANDA 077853............ Metformin HCl Tablets Provident
USP, 500 mg, 850 mg, Pharmaceutical, Inc.,
and 1 g. c/o Vintage
Pharmaceuticals, LLC,
1400 Atwater Dr.,
Malvern, PA 19355.
ANDA 080355............ Hydrocortisone Tablets Watson Laboratories,
USP, 20 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc., Morris
Corporate Center III,
400 Interpace Pkwy.,
Parsippany, NJ 07054.
ANDA 080377............ Lidocaine HCl with Watson Laboratories,
Epinephrine Injection, Inc., Subsidiary of
1%; 0.01 mg/mL and 2%; Teva Pharmaceuticals
0.01 mg/mL. USA, Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 087100............ Chlorthalidone Tablets Do.
USP, 25 mg.
ANDA 087211............ Methocarbamol and Ivax Pharmaceuticals,
Aspirin Tablets, 400 Inc., Subsidiary of
mg/325 mg. Teva Pharmaceuticals
USA, Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 090184............ Podofilox Topical Bausch & Lomb, Inc.,
Solution, 0.5%. Subsidiary of Valeant
Pharmaceuticals North
America, LLC, 400
Somerset Corporate
Blvd., Bridgewater,
NJ 08807.
ANDA 202002............ Imiquimod Cream, 5%.... Strides Pharma Global
Pte Ltd., c/o Strides
Pharma, Inc., 2 Tower
Center Blvd., Suite
1102, East Brunswick,
NJ 08816.
ANDA 203247............ Sodium Fluoride F-18 University of Texas MD
Injection, 10-200 Anderson Cancer
millicurie (mCi)/mL. Center, Cyclotron
Radiochemistry
Facility, 1881 East
Rd., Unit 1903,
Houston, TX 77054.
ANDA 203933............ Ammonia N-13 Injection, Do.
3.75-37.5 mCi/mL.
ANDA 205072............ Cefadroxil Capsules CSPC Ouyi
USP, EQ 500 mg base. Pharmaceutical Co.,
Ltd., c/o Megalith
Pharmaceuticals,
Inc., 9625 Hillside
Rd., Rancho
Cucamonga, CA 91737.
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Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
October 29, 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 October 29, 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: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21199 Filed 9-27-18; 8:45 am]
BILLING CODE 4164-01-P