Document ID: FDA-2017-N-5226-0001
Agency: fda
Document Type: Notice
Title: Department of Health and Human Services, Supply Service Center et al.;
Withdrawal of Approval of 27 Abbreviated New Drug Applications
Posted Date: 2017-09-21T04:00Z

[Federal Register Volume 82, Number 182 (Thursday, September 21, 2017)]
[Notices]
[Pages 44185-44187]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-20107]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5526]

Department of Health and Human Services, Supply Service Center et 
al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval 
of 27 abbreviated new drug applications (ANDAs) from multiple 
applicants. The holders of the applications notified the Agency in 
writing that the drug products were no longer marketed and requested 
that the approval of the applications be withdrawn.

DATES: Applied Date: October 23, 2017.

[[Page 44186]]

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 holders of the applications listed in 
table 1 have informed FDA that these drug products are no longer 
marketed and have requested that FDA withdraw approval of the 
applications under the process 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 abbreviated application 
under Sec.  314.150(c) is without prejudice to refiling.

                                 Table 1
------------------------------------------------------------------------
       Application No.                Drug                Applicant
------------------------------------------------------------------------
ANDA 061071.................  Tetracycline          Department of Health
                               Hydrochloride (HCl)   and Human Services,
                               Tablets, 250          Supply Service
                               milligrams (mg).      Center, PSC Bldg.
                                                     14 Boiler House
                                                     Rd., Perry Point,
                                                     MD 21902.
ANDA 062279.................  Grifulvin V           Valeant
                               (griseofulvin         Pharmaceuticals
                               microsize) Tablets    North America, LLC,
                               USP,125 mg, 250 mg,   400 Somerset
                               and 500 mg.           Corporate Blvd.,
                                                     Bridgewater, NJ
                                                     08807.
ANDA 062398.................  Cephalexin Capsules,  Department of Health
                               250 mg and 500 mg.    and Human Services,
                                                     Supply Service
                                                     Center, PSC Bldg.
                                                     14 Boiler House
                                                     Rd., Perry Point,
                                                     MD 21902.
ANDA 062756.................  Primaxin (cilastatin  Merck Sharp & Dohme
                               sodium and            Corp., Subsidiary
                               imipenem) for         of Merck & Co.,
                               Injection,            Inc., 1 Merck Dr.,
                               Equivalent to (EQ)    P.O. Box 100,
                               250 mg base/vial;     Whitehouse Station,
                               250 mg/vial and EQ    NJ 08889.
                               500 mg base/vial;
                               500 mg/vial.
ANDA 062814.................  Gentamicin Sulfate    B. Braun Medical
                               in 0.9% Sodium        Inc., 901 Marcon
                               Chloride Injection,   Blvd., Allentown,
                               EQ 0.8 mg base/       PA 18109.
                               milliliter (mL), EQ
                               1.2 mg base/mL, EQ
                               1.4 mg base/mL, EQ
                               1.6 mg base/mL, EQ
                               1.8 mg base/mL, EQ
                               2 mg base/mL, EQ
                               2.4 mg base/mL, EQ
                               40 mg base/100 mL,
                               EQ 60 mg base/100
                               mL, EQ 70 mg base/
                               100 mL, EQ 80 mg
                               base/100 mL, EQ 90
                               mg base/100 mL, EQ
                               100 mg base/100 mL,
                               and EQ 120 mg base/
                               100 mL.
ANDA 063239.................  Rocephin              Hoffmann-La Roche,
                               (ceftriaxone          Inc., c/o Genentech
                               sodium) for           Inc., 1 DNA Way, MS
                               Injection USP, EQ     241B, South San
                               250 mg base/vial,     Francisco, CA
                               EQ 500 mg base/       94080.
                               vial, and EQ 1 gram
                               (g) base/vial.
ANDA 064127.................  Erythromycin Topical  Renaissance Pharma,
                               Solution, 2%.         Inc., 411 South
                                                     State St., Suite E-
                                                     100, Newton, PA
                                                     18940.
ANDA 064146.................  Amikacin Sulfate in   Hospira, Inc.,
                               Sodium Chloride       Subsidiary of
                               0.9% Injection, EQ    Pfizer Inc., 375 N.
                               500 mg base/100 mL.   Field Dr., Lake
                                                     Forest, IL 60045.
ANDA 070598.................  Metoclopramide HCl    Merck Sharp & Dohme
                               Tablets, EQ 10 mg     Corp., Subsidiary
                               base.                 of Merck & Co.,
                                                     Inc.
ANDA 072080.................  Furosemide Injection  Hospira, Inc.,
                               USP, 10 mg/mL.        Subsidiary of
                                                     Pfizer Inc.
ANDA 074601.................  Dipyridamole           Do.
                               Injection, 5 mg/mL.
ANDA 074720.................  Acyclovir Sodium       Do.
                               Injection, EQ 25 mg
                               base/mL.
ANDA 076564.................  Adenosine Injection   Teva Pharmaceuticals
                               USP, 3 mg/mL.         USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 078211.................  Quinapril HCl and     Sun Pharmaceutical
                               Hydrochlorothiazide   Industries Ltd., c/
                               Tablets, EQ 10 mg     o Sun
                               base/12.5 mg, EQ 20   Pharmaceutical
                               mg base/12.5 mg,      Industries, Inc., 2
                               and EQ 20 mg base/    Independence Way,
                               25 mg.                Princeton, NJ
                                                     08540.
ANDA 078935.................  Tramadol HCl Tablets  Northstar Healthcare
                               USP, 50 mg.           Holdings, c/o
                                                     Quality Regulatory
                                                     Consultants, 1966
                                                     Anglers Cove, Vero
                                                     Beach, FL 32963.
ANDA 080810.................  Halothane USP,        Halocarbon Products
                               99.99%.               Corp., 1100 Dittman
                                                     Ct., North Augusta,
                                                     SC 29841.
ANDA 085458.................  Dexamethasone         Watson Laboratories,
                               Tablets USP, 0.5 mg.  Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 085883.................  Acetaminophen and     Actavis Mid Atlantic
                               Codeine Phosphate     LLC, Subsidiary of
                               Oral Suspension       Teva
                               USP, 120 mg/5 mL      Pharmaceuticals
                               and 12 mg/5 mL.       USA, Inc., 425
                                                     Privet Rd.,
                                                     Horsham, PA 19044.
ANDA 085884.................  Cortisone Acetate     Watson Laboratories,
                               Tablets USP, 25 mg.   Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, Inc.
ANDA 086179.................  Carisoprodol Tablets   Do.
                               USP, 350 mg.
ANDA 086440.................  Atropine Sulfate and  Catalent Pharma
                               Diphenoxylate HCl     Solutions, Inc.,
                               Capsules, 0.025 mg/   2725 Scherer Dr.
                               2.5 mg.               North, St.
                                                     Petersburg, FL
                                                     33716.
ANDA 087535.................  Methylprednisolone    Organon USA, Inc.,
                               Sodium Succinate      Subsidiary of Merck
                               for Injection USP,    and Co., Inc., 126
                               EQ 500 mg base/vial   E. Lincoln Ave.,
                               and EQ 1 g base/      P.O. Box 2000,
                               vial.                 Rahway, NJ 07065.
ANDA 087711.................  Dexamethasone         Watson Laboratories,
                               Acetate Injectable    Inc., Subsidiary of
                               Suspension USP, EQ    Teva
                               16 mg base/mL.        Pharmaceuticals
                                                     USA, Inc.
ANDA 088346.................  Heparin Lock Flush    Hospira, Inc.
                               Solution USP and
                               0.9% Sodium
                               Chloride Injection
                               USP, 10 USP heparin
                               units/mL and 100
                               USP heparin units/
                               mL.
ANDA 088852.................  Chlorpropamide        Watson Laboratories,
                               Tablets USP, 100 mg.  Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, Inc.

[[Page 44187]]

 
ANDA 091201.................  Meropenem for         Sandoz Inc., 100
                               Injection USP, 500    College Rd. West,
                               mg/vial and 1 g/      Princeton, NJ
                               vial.                 08540.
ANDA 200156.................  Armodafinil Tablets,  Watson Laboratories,
                               100 mg and 200 mg.    Inc., Subsidiary of
                                                     Teva
                                                     Pharmaceuticals
                                                     USA, Inc.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in table 1, and all 
amendments and supplements thereto, is hereby withdrawn, effective 
October 23, 2017. 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 table 
1 that are in inventory on the date that this notice becomes effective 
(see the DATES section) 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 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20107 Filed 9-20-17; 8:45 a.m.]
 BILLING CODE 4164-01-P