Document ID: FDA-2017-N-5715-0001
Agency: fda
Document Type: Notice
Title: Watson Laboratories, Inc., and Barr Laboratories, Inc., Subsidiaries of Teva
Pharmaceuticals USA, Inc.; Withdrawal of Approval of 54 Abbreviated New Drug Applications
Posted Date: 2017-10-24T04:00Z

[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)]
[Notices]
[Pages 49214-49215]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-23046]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-5715]

Watson Laboratories, Inc., and Barr Laboratories, Inc., 
Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval 
of 54 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 54 abbreviated new drug applications (ANDAs) from two 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of the applications be withdrawn.

DATES: Approval is withdrawn as of November 24, 2017.

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 061717..................  Doxycycline Hyclate   Watson
                                Capsules USP,         Laboratories,
                                Equivalent to (EQ)    Inc., Subsidiary
                                50 milligrams (mg)    of Teva
                                base and EQ 100 mg    Pharmaceuticals
                                base.                 USA, Inc., 425
                                                      Privet Rd.,
                                                      Horsham, PA 19044.
ANDA 062087..................  Erythromycin           Do.
                                Estolate Capsules
                                USP, EQ 250 mg base.
ANDA 062318..................  Gentamicin Injection   Do.
                                USP, EQ 10 mg base/
                                milliliter (mL) and
                                EQ 40 mg base/mL.
ANDA 062816..................  Ampicillin for         Do.
                                Injection USP, EQ
                                125 mg base/vial,
                                EQ 250 mg base/
                                vial, EQ 500 mg
                                base/vial, EQ 1
                                gram (g) base/vial,
                                and EQ 2 g base/
                                vial.
ANDA 062994..................  Ampicillin for         Do.
                                Injection USP, EQ
                                10 g base/vial.
ANDA 062999..................  Erythromycin Delayed- Barr Laboratories,
                                Release Tablets       Inc., Subsidiary
                                USP, 500 mg.          of Teva
                                                      Pharmaceuticals
                                                      USA, Inc., 425
                                                      Privet Rd.,
                                                      Horsham, PA 19044.
ANDA 064036..................  Cefuroxime for        Watson
                                Injection USP, EQ     Laboratories,
                                7.5 g base/vial.      Inc., Subsidiary
                                                      of Teva
                                                      Pharmaceuticals
                                                      USA, Inc.
ANDA 070296..................  Diazepam Injection     Do.
                                USP, 5 mg/mL.
ANDA 070412..................  Furosemide Tablets     Do.
                                USP, 20 mg.
ANDA 070435..................  Ibuprofen Tablets      Do.
                                USP, 200 mg.
ANDA 070436..................  Ibuprofen Tablets      Do.
                                USP, 400 mg.
ANDA 070437..................  Ibuprofen Tablets      Do.
                                USP, 600 mg.
ANDA 070449..................  Furosemide Tablets     Do.
                                USP, 20 mg.
ANDA 070450..................  Furosemide Tablets     Do.
                                USP, 40 mg.
ANDA 070515..................  Tolazamide Tablets     Do.
                                USP, 500 mg.
ANDA 070528..................  Furosemide Tablets     Do.
                                USP, 80 mg.
ANDA 071238..................  Doxepin                Do.
                                Hydrochloride (HCl)
                                Capsules USP, EQ 50
                                mg base.
ANDA 071547..................  Ibuprofen Tablets      Do.
                                USP, 800 mg.
ANDA 072397..................  Diazepam Injection     Do.
                                USP, 5 mg/mL.
ANDA 072407..................  Fenoprofen Calcium     Do.
                                Tablets USP, EQ 600
                                mg base.
ANDA 072602..................  Fenoprofen Calcium     Do.
                                Tablets USP, EQ 600
                                mg base.
ANDA 072630..................  Albuterol Tablets      Do.
                                USP, EQ 4 mg base.
ANDA 072825..................  Baclofen Tablets       Do.
                                USP, 20 mg.
ANDA 073013..................  Metaproterenol         Do.
                                Sulfate Tablets
                                USP, 10 mg.
ANDA 073445..................  Meperidine HCl         Do.
                                Injection USP, 100
                                mg/mL.
ANDA 074025..................  Guanabenz Acetate      Do.
                                Tablets USP, EQ 4
                                mg base and EQ 8 mg
                                base.
ANDA 074114..................  Dobutamine Injection   Do.
                                USP, EQ 12.5 mg
                                base/mL.
ANDA 074163..................  Naproxen Tablets       Do.
                                USP, 250 mg, 375
                                mg, and 500 mg.
ANDA 074287..................  Piroxicam Capsules     Do.
                                USP, 10 mg and 20
                                mg.
ANDA 074303..................  Pentamidine            Do.
                                Isethionate for
                                Injection, 300 mg/
                                vial.
ANDA 074437..................  Pindolol Tablets       Do.
                                USP, 5 mg and 10 mg.
ANDA 074456..................  Alprazolam Tablets     Do.
                                USP, 0.25 mg, 0.5
                                mg, and 1 mg.
ANDA 077643..................  Topiramate Tablets     Do.
                                USP, 25 mg, 50 mg,
                                100 mg, and 200 mg.
ANDA 080728..................  Diphenhydramine HCl    Do.
                                Capsules USP, 25 mg.
ANDA 080968..................  Dexamethasone          Do.
                                Tablets USP, 0.75
                                mg.
ANDA 081040..................  Chlorzoxazone          Do.
                                Tablets USP, 500 mg.
ANDA 081149..................  Hydroxyzine HCl        Do.
                                Tablets USP, 10 mg.
ANDA 081189..................  Hydrochlorothiazide    Do.
                                Tablets USP, 25 mg.
ANDA 081216..................  Estropipate Tablets    Do.
                                USP, 6 mg.
ANDA 083232..................  Hydrochlorothiazide    Do.
                                Tablets USP, 50 mg.

[[Page 49215]]

 
ANDA 085720..................  Meprobamate Tablets    Do.
                                USP, 200 mg.
ANDA 085721..................  Meprobamate Tablets    Do.
                                USP, 400 mg.
ANDA 085778..................  Hydroxyzine HCl        Do.
                                Injection USP, 25
                                mg/mL.
ANDA 086096..................  Chlorpheniramine       Do.
                                Maleate Injection
                                USP, 10 mg/mL.
ANDA 086189..................  Ergoloid Mesylates     Do.
                                Sublingual Tablets
                                USP, 0.5 mg.
ANDA 086598..................  Nandrolone Decanoate   Do.
                                Injection USP, 100
                                mg/mL.
ANDA 086795..................  Chlorothiazide         Do.
                                Tablets USP, 250 mg.
ANDA 087183..................  Ergoloid Mesylates     Do.
                                Sublingual Tablets
                                USP, 1 mg.
ANDA 087296..................  Chlorthalidone         Do.
                                Tablets USP, 25 mg.
ANDA 087521..................  Chlorthalidone         Do.
                                Tablets USP, 50 mg.
ANDA 087772..................  Prednisone Tablets     Do.
                                USP, 50 mg.
ANDA 087979..................  Chloroquine            Do.
                                Phosphate Tablets
                                USP, EQ 150 mg base.
ANDA 088030..................  Chloroquine            Do.
                                Phosphate Tablets
                                USP, EQ 300 mg base.
ANDA 089042..................  Procainamide HCl       Do.
                                Extended-Release
                                Tablets USP, 750 mg.
------------------------------------------------------------------------

    Therefore, approval of the applications listed in table 1, and all 
amendments and supplements thereto, is hereby withdrawn as of November 
24, 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: October 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-23046 Filed 10-23-17; 8:45 am]
 BILLING CODE 4164-01-P