Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. et al.; Withdrawal of Approval of 111 Abbreviated New Drug Applications, 128-131 [2017-28254]
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Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices
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SUPPLEMENTARY INFORMATION:
Agenda: The committees will be
asked to discuss new drug application
(NDA) 209257, proposed tradename,
HYDEXOR, a fixed-dose combination
oral tablet, submitted by Charleston
Laboratories, Inc., that contains
hydrocodone, acetaminophen, and
promethazine, for the short-term
management of acute pain severe
enough to require an opioid analgesic
while preventing and reducing opioidinduced nausea and vomiting. The
committees will also be asked to discuss
the abuse potential of this non-abusedeterrent product and whether it should
be approved.
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Dated: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–28250 Filed 12–29–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6852]
Watson Laboratories, Inc., Subsidiary
of Teva Pharmaceuticals USA, Inc. et
al.; Withdrawal of Approval of 111
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 111
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applications be withdrawn.
DATES: Approval is withdrawn as of
February 1, 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,
SUMMARY:
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Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
The
holders of the applications listed in
table 1 have informed FDA that these
SUPPLEMENTARY INFORMATION:
drug products are no longer marketed
and have requested that FDA withdraw
approval of the applications under the
process in § 314.150(c) (21 CFR
314.150(c)). The applicants have also,
by their requests, waived their
129
opportunity for a hearing. Withdrawal
of approval of an application or
abbreviated application under
§ 314.150(c) is without prejudice to
refiling.
TABLE 1
Application
No.
Drug
Applicant
ANDA 040008
Heparin Sodium Injection USP, 1000 units/milliliter (mL) ..........
ANDA 040137
ANDA 040410
Chlorzoxazone Tablets USP, 500 milligrams (mg) ....................
Methylphenidate Hydrochloride (HCl) Extended-Release Tablets USP, 20 mg.
Amphetamine Aspartate; Amphetamine Sulfate; Dextroamphetamine Saccharate; Dextroamphetamine Sulfate Tablets, 1.25 mg/1.25 mg/1.25 mg/1.25 mg, 2.5 mg/2.5 mg/2.5
mg/2.5 mg, 5 mg/5 mg/5 mg/5 mg, and 7.5 mg/7.5 mg/7.5
mg/7.5 mg.
A-Hydrocort (hydrocortisone sodium succinate) for Injection
USP, Equivalent to (EQ) 100 mg base/vial.
Kanamycin Sulfate Injection, EQ 1 gram (g) base/3 mL ............
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Do.
Do.
ANDA 040456
ANDA 040666
ANDA 062520
ANDA 062693
ANDA 070468
Cephradine for Oral Suspension USP, 125 mg/5 mL and 250
mg/5 mL.
Nafcillin for Injection USP, EQ 500 mg base/vial, EQ 1 g base/
vial, EQ 1.5 g base/vial, EQ 2 g base/vial, and EQ 4 g base/
vial.
Oxacillin for Injection USP, EQ 250 mg base/vial, EQ 500 mg
base/vial, EQ 1 g base/vial, EQ 2 g base/vial, and EQ 4 g
base/vial.
Oxacillin for Injection USP, EQ 10 g base/vial (Pharmacy Bulk
Package).
Penicillin G Potassium for Injection USP, 1 million units/vial, 5
million units/vial, 10 million units/vial, and 20 million units/vial.
Nafcillin for Injection USP, EQ 10 g base/vial (Pharmacy Bulk
Package).
Penicillin G Sodium for Injection USP, 5 million units/vial .........
Gentamicin Injection USP, EQ 40 mg base/mL .........................
Cefuroxime for Injection USP, EQ 750 mg base/vial and EQ
1.5 g base/vial.
Cefazolin for Injection USP, EQ 500 mg base/vial and EQ 1 g
base/vial.
Ceftriaxone for Injection USP, EQ 250 mg base/vial, EQ 500
mg base/vial, EQ 1 g base/vial, and EQ 2 g base/vial.
Cefazolin for Injection USP, EQ 10 g base/vial (Pharmacy Bulk
Package).
Cefazolin for Injection USP, EQ 20 g base/vial (Pharmacy Bulk
Package).
Propranolol HCl and Hydrochlorothiazide Tablets USP, 40 mg/
25 mg.
Propranolol HCl and Hydrochlorothiazide Tablets USP, 80 mg/
25 mg.
Verapamil HCl Tablets USP, 120 mg .........................................
ANDA 070549
Propranolol HCl Tablets USP, 20 mg .........................................
ANDA 070703
ANDA 070714
ANDA 070851
Methyldopa Tablets USP, 250 mg ..............................................
Haloperidol Injection USP, EQ 5 mg base/mL ...........................
Propranolol HCl and Hydrochlorothiazide Tablets USP, 40 mg/
25 mg.
Propranolol HCl and Hydrochlorothiazide Tablets USP, 80 mg/
25 mg.
Verapamil HCl Tablets USP, 80 mg ...........................................
ANDA 062844
ANDA 062856
ANDA 062984
ANDA 062991
ANDA 063008
ANDA 063014
ANDA 063106
ANDA 064035
ANDA 065280
ANDA 065294
ANDA 065295
ANDA 065296
ANDA 070301
ANDA 070305
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ANDA 070852
ANDA 070855
ANDA 070958
ANDA 070959
ANDA 070960
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Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/15
mg.
Methyldopa and Hydrochlorothiazide Tablets USP, 250 mg/25
mg.
Methyldopa and Hydrochlorothiazide Tablets USP, 500 mg/50
mg.
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Actavis Elizabeth, LLC, Subsidiary of Teva Pharmaceuticals
USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Hospira, Inc., a Pfizer Company, 275 North Field Dr., Bldg.
H1, Lake Forest, IL 60045.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Do.
Do.
Do.
Do.
Teva Pharmaceuticals USA, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Cephazone Pharma, LLC, 250 E. Bonita Ave., Pomona, CA
91767.
Do.
Do.
Do.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Actavis Elizabeth, LLC, Subsidiary of Teva Pharmaceuticals
USA, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Do.
Actavis Elizabeth, LLC, Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Do.
Do.
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Federal Register / Vol. 83, No. 1 / Tuesday, January 2, 2018 / Notices
TABLE 1—Continued
Application
No.
Drug
ANDA 071069
071110
071117
071118
071485
071486
071666
Methyldopa and Hydrochlorothiazide Tablets USP, 500 mg/30
mg.
Lorazepam Tablets USP, 2 mg ..................................................
Lorazepam Tablets USP, 0.5 mg ...............................................
Lorazepam Tablets USP, 1 mg ..................................................
Doxepin HCl Capsules USP, EQ 10 mg base ...........................
Doxepin HCl Capsules USP, EQ 25 mg base ...........................
Ibuprofen Tablets, 400 mg ..........................................................
ANDA 071792
Propranolol HCl Tablets USP, 90 mg .........................................
ANDA 071883
ANDA 071919
Betamethasone Valerate Lotion USP, EQ 0.1% base ...............
Nalidixic Acid Tablets USP, 1 g ..................................................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
Nalidixic Acid Tablets USP, 250 mg ...........................................
Nalidixic Acid Tablets USP, 500 mg ...........................................
Maprotiline HCl Tablets USP, 75 mg .........................................
Metaproterenol Sulfate Tablets USP, 20 mg ..............................
Baclofen Tablets USP, 10 mg ....................................................
Morphine Sulfate Injection USP, 1 mg/2 mL (Ampule) ..............
Morphine Sulfate Injection USP, 10 mg/10 mL (Ampule) ..........
Morphine Sulfate Injection USP, 5 mg/10 mL (Vial) ..................
Morphine Sulfate Injection USP, 10 mg/10 mL (Vial) ................
Meperidine HCl Injection USP, 10 mg/mL (Preservative Free)
Meperidine HCl Injection USP, 50 mg/mL ..................................
Doxapram HCl Injection USP, 20 mg/mL ...................................
Metoprolol Tartrate Injection USP, 1 mg/mL ..............................
Naproxen Sodium Tablets USP, EQ 250 mg base and EQ 500
mg base.
Lorazepam Injection USP, 2 mg/mL and 4 mg/mL ....................
Dobutamine .................................................................................
Injection USP, EQ 12.5 mg base/mL .........................................
Isoflurane USP, 99.9% ...............................................................
Naproxen Tablets USP, 250 mg, 375 mg, and 500 mg .............
Hydromorphone HCl Injection USP, 10 mg/mL ..........................
Ranitidine Tablets USP, EQ 150 mg base and EQ 300 mg
base.
Acyclovir Capsules USP, 200 mg ...............................................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
071936
072061
072164
072795
072824
073373
073374
073375
073376
073443
073444
073529
074032
074195
ANDA 074276
ANDA 074279
ANDA
ANDA
ANDA
ANDA
074393
074457
074598
074864
ANDA 074906
ANDA 075253
ANDA 075650
ANDA 075672
ANDA
ANDA
ANDA
ANDA
075843
075901
075960
076689
ANDA 077174
ANDA 077963
ANDA 080615
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ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
080713
081150
081151
083287
084280
084403
084467
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
085083
085140
085173
085180
085192
085597
Applicant
Ticlopidine HCl Tablets, 250 mg ................................................
Famotidine Tablets USP, 20 mg and 40 mg ..............................
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, 2.5 mg/
6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg.
Oxaprozin Tablets, 600 mg ........................................................
Fluvoxamine Maleate Tablets, 25 mg, 50 mg, and 100 mg ......
Tramadol HCl Tablets, 50 mg ....................................................
Mirtazapine Orally Disintegrating Tablets USP, 15 mg, 30 mg,
and 45 mg.
Foscarnet Sodium Injection, 2.4 g/100 mL .................................
Granisetron HCl Injection, EQ 1 mg base/mL ............................
Dimenhydrinate Injection, 50 mg/mL ..........................................
ANDA 086013
ANDA 086029
Tripelennamine HCl Tablets USP, 50 mg ..................................
Hydroxyzine HCl Tablets USP, 25 mg .......................................
Hydroxyzine HCl Tablets USP, 50 mg .......................................
Procainamide HCl Capsules USP, 250 mg ................................
Procainamide HCl Capsules USP, 500 mg ................................
Procainamide HCl Capsules USP, 375 mg ................................
Reserpine and Hydrochlorothiazide Tablets USP, 0.125 mg/50
mg.
Diphenhydramine HCl Capsules USP, 50 mg ............................
Quinidine Sulfate Tablets USP, 200 mg .....................................
Chlorothiazide Tablets USP, 250 mg .........................................
Methocarbamol Tablets USP, 500 mg .......................................
Methocarbamol Tablets USP, 750 mg .......................................
Methylprednisolone Acetate Injectable Suspension USP, 20
mg/mL.
Statobex (phendimetrazine tartrate) Tablets USP, 35 mg .........
Testosterone Cypionate Injection USP, 100 mg/mL ..................
ANDA 086031
Isosorbide Dinitrate Sublingual Tablets USP, 5 mg ...................
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Do.
Do.
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Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425
Privet Rd., Horsham, PA 19044.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Teva Pharmaceuticals USA, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Hospira, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Actavis Elizabeth, LLC, Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Hospira, Inc.
Teva Pharmaceuticals USA, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Teva Pharmaceuticals USA, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
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131
TABLE 1—Continued
Application
No.
Drug
Applicant
ANDA 086742
Isosorbide Dinitrate Tablets USP, 5 mg .....................................
Gerimal (ergoloid mesylates) Sublingual Tablets, 1 mg ............
Nandrolone Decanoate Injection, 50 mg/mL ..............................
Wigraine (ergotamine tartrate and caffeine) Tablets USP, 1
mg/100 mg.
Choledyl SA (oxtriphylline) Extended-Release Tablets, 600 mg
ANDA 086863
Chlorpromazine HCl Oral Concentrate USP, 100 mg/mL ..........
ANDA 087233
Ergoloid Mesylates Sublingual Tablets USP, 0.5 mg .................
ANDA 087244
ANDA
087318..
ANDA 087727
Ergoloid Mesylates Tablets USP, 1 mg ......................................
Tolbutamide Tablets USP, 500 mg ............................................
Do.
Do.
Do.
Organon USA, Inc., Subsidiary of Merck & Co., Inc., 2000 Galloping Hill Rd., Kenilworth, NJ 07033.
Warner Chilcott Co., LLC, Subsidiary of Teva Pharmaceuticals
USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals
USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Do.
ANDA 088128
Nandrolone Decanoate Injection, 200 mg/mL ............................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
088337
088477
088561
088564
088724
088734
088769
Ergostat (ergotamine tartrate) Sublingual Tablets USP, 2 mg ...
Thioridazine HCl Tablets USP, 15 mg .......................................
Thioridazine HCl Tablets USP, 10 mg .......................................
Thioridazine HCl Tablets USP, 100 mg .....................................
Methyclothiazide Tablets USP, 5 mg .........................................
Meclizine HCl Tablets, 25 mg .....................................................
Mepivacaine HCl Injection USP, 1% ..........................................
ANDA
ANDA
ANDA
ANDA
ANDA
088770
088872
089026
089027
089530
Mepivacaine HCl Injection USP, 2% ..........................................
Thioridazine HCl Tablets USP, 200 mg .....................................
Procainamide HCl Extended-Release Tablets USP, 250 mg ....
Procainamide HCl Extended-Release Tablets USP, 500 mg ....
Prochlorperazine Edisylate Injection USP, EQ 5 mg base/mL ..
ANDA
ANDA
ANDA
ANDA
086034
086188
086385
086562
Aminophylline Oral Solution USP, 105 mg/5 mL (Dye Free) .....
Therefore, approval of the
applications listed in table 1, and all
amendments and supplements thereto,
is hereby withdrawn as of February 1,
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 table 1
that are in inventory on the date that
this notice becomes effective (see DATES)
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: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–28254 Filed 12–29–17; 8:45 am]
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BILLING CODE 4164–01–P
VerDate Sep<11>2014
19:54 Dec 29, 2017
Jkt 244001
Actavis Mid Atlantic, LLC, Subsidiary of Teva Pharmaceuticals
USA, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Do.
Do.
Do.
Do.
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc.
Do.
Do.
Do.
Do.
Do.
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; Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
The Food and Drug
Administration (FDA) is correcting a
notice that appeared in the Federal
Register of October 24, 2017. The
document announced the withdrawal of
approval of 54 abbreviated new drug
applications (ANDAs) from two
applicants, effective November 24, 2017.
The notice inadvertently announced the
withdrawal of approval for ANDA
087296 for Chlorthalidone Tablets USP,
25 milligrams, held by Watson
Laboratories, Inc., a subsidiary of Teva
Pharmaceuticals USA, Inc., 425 Privet
Rd., Horsham, PA 19044. FDA confirms
that the approval of ANDA 087296 is
still in effect.
SUMMARY:
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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: In FR Doc.
2017–23046, appearing on page 49214
in the Federal Register of Tuesday,
October 24, 2017, the following
correction is made:
1. On page 49215, in table 1, the entry
for ANDA 087296 is removed.
Dated: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–28253 Filed 12–29–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–1846]
Labeling for Combined Hormonal
Contraceptives; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
E:\FR\FM\02JAN1.SGM
02JAN1
]]>Agencies
[Federal Register Volume 83, Number 1 (Tuesday, January 2, 2018)]
[Notices]
[Pages 128-131]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-28254]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6852]
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals
USA, Inc. et al.; Withdrawal of Approval of 111 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 111 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: Approval is withdrawn as of February 1, 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,
[[Page 129]]
MD 20993-0002, 240-402-7945, [email protected].
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 application or abbreviated
application under Sec. 314.150(c) is without prejudice to refiling.
Table 1
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Application No. Drug Applicant
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ANDA 040008......... Heparin Sodium Injection Watson Laboratories,
USP, 1000 units/ Inc., Subsidiary of
milliliter (mL). Teva Pharmaceuticals
USA, Inc., 425 Privet
Rd., Horsham, PA 19044.
ANDA 040137......... Chlorzoxazone Tablets Do.
USP, 500 milligrams
(mg).
ANDA 040410......... Methylphenidate Do.
Hydrochloride (HCl)
Extended-Release
Tablets USP, 20 mg.
ANDA 040456......... Amphetamine Aspartate; Actavis Elizabeth, LLC,
Amphetamine Sulfate; Subsidiary of Teva
Dextroamphetamine Pharmaceuticals USA,
Saccharate; Inc., 425 Privet Rd.,
Dextroamphetamine Horsham, PA 19044.
Sulfate Tablets, 1.25
mg/1.25 mg/1.25 mg/1.25
mg, 2.5 mg/2.5 mg/2.5
mg/2.5 mg, 5 mg/5 mg/5
mg/5 mg, and 7.5 mg/7.5
mg/7.5 mg/7.5 mg.
ANDA 040666......... A-Hydrocort Hospira, Inc., a Pfizer
(hydrocortisone sodium Company, 275 North
succinate) for Field Dr., Bldg. H1,
Injection USP, Lake Forest, IL 60045.
Equivalent to (EQ) 100
mg base/vial.
ANDA 062520......... Kanamycin Sulfate Watson Laboratories,
Injection, EQ 1 gram Inc., Subsidiary of
(g) base/3 mL. Teva Pharmaceuticals
USA, Inc.
ANDA 062693......... Cephradine for Oral Teva Pharmaceuticals
Suspension USP, 125 mg/ USA, Inc., 425 Privet
5 mL and 250 mg/5 mL. Rd., Horsham, PA 19044.
ANDA 062844......... Nafcillin for Injection Watson Laboratories,
USP, EQ 500 mg base/ Inc., Subsidiary of
vial, EQ 1 g base/vial, Teva Pharmaceuticals
EQ 1.5 g base/vial, EQ USA, Inc.
2 g base/vial, and EQ 4
g base/vial.
ANDA 062856......... Oxacillin for Injection Do.
USP, EQ 250 mg base/
vial, EQ 500 mg base/
vial, EQ 1 g base/vial,
EQ 2 g base/vial, and
EQ 4 g base/vial.
ANDA 062984......... Oxacillin for Injection Do.
USP, EQ 10 g base/vial
(Pharmacy Bulk Package).
ANDA 062991......... Penicillin G Potassium Do.
for Injection USP, 1
million units/vial, 5
million units/vial, 10
million units/vial, and
20 million units/vial.
ANDA 063008......... Nafcillin for Injection Do.
USP, EQ 10 g base/vial
(Pharmacy Bulk Package).
ANDA 063014......... Penicillin G Sodium for Do.
Injection USP, 5
million units/vial.
ANDA 063106......... Gentamicin Injection Teva Pharmaceuticals
USP, EQ 40 mg base/mL. USA, Inc.
ANDA 064035......... Cefuroxime for Injection Watson Laboratories,
USP, EQ 750 mg base/ Inc., Subsidiary of
vial and EQ 1.5 g base/ Teva Pharmaceuticals
vial. USA, Inc.
ANDA 065280......... Cefazolin for Injection Cephazone Pharma, LLC,
USP, EQ 500 mg base/ 250 E. Bonita Ave.,
vial and EQ 1 g base/ Pomona, CA 91767.
vial.
ANDA 065294......... Ceftriaxone for Do.
Injection USP, EQ 250
mg base/vial, EQ 500 mg
base/vial, EQ 1 g base/
vial, and EQ 2 g base/
vial.
ANDA 065295......... Cefazolin for Injection Do.
USP, EQ 10 g base/vial
(Pharmacy Bulk Package).
ANDA 065296......... Cefazolin for Injection Do.
USP, EQ 20 g base/vial
(Pharmacy Bulk Package).
ANDA 070301......... Propranolol HCl and Watson Laboratories,
Hydrochlorothiazide Inc., Subsidiary of
Tablets USP, 40 mg/25 Teva Pharmaceuticals
mg. USA, Inc.
ANDA 070305......... Propranolol HCl and Do.
Hydrochlorothiazide
Tablets USP, 80 mg/25
mg.
ANDA 070468......... Verapamil HCl Tablets Actavis Elizabeth, LLC,
USP, 120 mg. Subsidiary of Teva
Pharmaceuticals USA,
Inc.
ANDA 070549......... Propranolol HCl Tablets Watson Laboratories,
USP, 20 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 070703......... Methyldopa Tablets USP, Do.
250 mg.
ANDA 070714......... Haloperidol Injection Do.
USP, EQ 5 mg base/mL.
ANDA 070851......... Propranolol HCl and Actavis Elizabeth, LLC,
Hydrochlorothiazide Subsidiary of Teva
Tablets USP, 40 mg/25 Pharmaceuticals USA,
mg. Inc.
ANDA 070852......... Propranolol HCl and Do.
Hydrochlorothiazide
Tablets USP, 80 mg/25
mg.
ANDA 070855......... Verapamil HCl Tablets Watson Laboratories,
USP, 80 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 070958......... Methyldopa and Do.
Hydrochlorothiazide
Tablets USP, 250 mg/15
mg.
ANDA 070959......... Methyldopa and Do.
Hydrochlorothiazide
Tablets USP, 250 mg/25
mg.
ANDA 070960......... Methyldopa and Do.
Hydrochlorothiazide
Tablets USP, 500 mg/50
mg.
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ANDA 071069......... Methyldopa and Do.
Hydrochlorothiazide
Tablets USP, 500 mg/30
mg.
ANDA 071110......... Lorazepam Tablets USP, 2 Do.
mg.
ANDA 071117......... Lorazepam Tablets USP, Do.
0.5 mg.
ANDA 071118......... Lorazepam Tablets USP, 1 Do.
mg.
ANDA 071485......... Doxepin HCl Capsules Do.
USP, EQ 10 mg base.
ANDA 071486......... Doxepin HCl Capsules Do.
USP, EQ 25 mg base.
ANDA 071666......... Ibuprofen Tablets, 400 Pliva, Inc., Subsidiary
mg. of Teva Pharmaceuticals
USA, Inc., 425 Privet
Rd., Horsham, PA 19044.
ANDA 071792......... Propranolol HCl Tablets Watson Laboratories,
USP, 90 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 071883......... Betamethasone Valerate Teva Pharmaceuticals
Lotion USP, EQ 0.1% USA, Inc.
base.
ANDA 071919......... Nalidixic Acid Tablets Watson Laboratories,
USP, 1 g. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 071936......... Nalidixic Acid Tablets Do.
USP, 250 mg.
ANDA 072061......... Nalidixic Acid Tablets Do.
USP, 500 mg.
ANDA 072164......... Maprotiline HCl Tablets Do.
USP, 75 mg.
ANDA 072795......... Metaproterenol Sulfate Do.
Tablets USP, 20 mg.
ANDA 072824......... Baclofen Tablets USP, 10 Do.
mg.
ANDA 073373......... Morphine Sulfate Do.
Injection USP, 1 mg/2
mL (Ampule).
ANDA 073374......... Morphine Sulfate Do.
Injection USP, 10 mg/10
mL (Ampule).
ANDA 073375......... Morphine Sulfate Do.
Injection USP, 5 mg/10
mL (Vial).
ANDA 073376......... Morphine Sulfate Do.
Injection USP, 10 mg/10
mL (Vial).
ANDA 073443......... Meperidine HCl Injection Do.
USP, 10 mg/mL
(Preservative Free).
ANDA 073444......... Meperidine HCl Injection Do.
USP, 50 mg/mL.
ANDA 073529......... Doxapram HCl Injection Do.
USP, 20 mg/mL.
ANDA 074032......... Metoprolol Tartrate Do.
Injection USP, 1 mg/mL.
ANDA 074195......... Naproxen Sodium Tablets Do.
USP, EQ 250 mg base and
EQ 500 mg base.
ANDA 074276......... Lorazepam Injection USP, Do.
2 mg/mL and 4 mg/mL.
ANDA 074279......... Dobutamine.............. Do.
Injection USP, EQ 12.5
mg base/mL.
ANDA 074393......... Isoflurane USP, 99.9%... Do.
ANDA 074457......... Naproxen Tablets USP, Do.
250 mg, 375 mg, and 500
mg.
ANDA 074598......... Hydromorphone HCl Hospira, Inc.
Injection USP, 10 mg/mL.
ANDA 074864......... Ranitidine Tablets USP, Watson Laboratories,
EQ 150 mg base and EQ Inc., Subsidiary of
300 mg base. Teva Pharmaceuticals
USA, Inc.
ANDA 074906......... Acyclovir Capsules USP, Actavis Elizabeth, LLC,
200 mg. Subsidiary of Teva
Pharmaceuticals USA,
Inc.
ANDA 075253......... Ticlopidine HCl Tablets, Do.
250 mg.
ANDA 075650......... Famotidine Tablets USP, Do.
20 mg and 40 mg.
ANDA 075672......... Bisoprolol Fumarate and Do.
Hydrochlorothiazide
Tablets, 2.5 mg/6.25
mg, 5 mg/6.25 mg, and
10 mg/6.25 mg.
ANDA 075843......... Oxaprozin Tablets, 600 Do.
mg.
ANDA 075901......... Fluvoxamine Maleate Do.
Tablets, 25 mg, 50 mg,
and 100 mg.
ANDA 075960......... Tramadol HCl Tablets, 50 Do.
mg.
ANDA 076689......... Mirtazapine Orally Do.
Disintegrating Tablets
USP, 15 mg, 30 mg, and
45 mg.
ANDA 077174......... Foscarnet Sodium Hospira, Inc.
Injection, 2.4 g/100 mL.
ANDA 077963......... Granisetron HCl Teva Pharmaceuticals
Injection, EQ 1 mg base/ USA, Inc.
mL.
ANDA 080615......... Dimenhydrinate Watson Laboratories,
Injection, 50 mg/mL. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 080713......... Tripelennamine HCl Do.
Tablets USP, 50 mg.
ANDA 081150......... Hydroxyzine HCl Tablets Do.
USP, 25 mg.
ANDA 081151......... Hydroxyzine HCl Tablets Do.
USP, 50 mg.
ANDA 083287......... Procainamide HCl Do.
Capsules USP, 250 mg.
ANDA 084280......... Procainamide HCl Do.
Capsules USP, 500 mg.
ANDA 084403......... Procainamide HCl Do.
Capsules USP, 375 mg.
ANDA 084467......... Reserpine and Do.
Hydrochlorothiazide
Tablets USP, 0.125 mg/
50 mg.
ANDA 085083......... Diphenhydramine HCl Do.
Capsules USP, 50 mg.
ANDA 085140......... Quinidine Sulfate Do.
Tablets USP, 200 mg.
ANDA 085173......... Chlorothiazide Tablets Do.
USP, 250 mg.
ANDA 085180......... Methocarbamol Tablets Do.
USP, 500 mg.
ANDA 085192......... Methocarbamol Tablets Do.
USP, 750 mg.
ANDA 085597......... Methylprednisolone Do.
Acetate Injectable
Suspension USP, 20 mg/
mL.
ANDA 086013......... Statobex Teva Pharmaceuticals
(phendimetrazine USA, Inc.
tartrate) Tablets USP,
35 mg.
ANDA 086029......... Testosterone Cypionate Watson Laboratories,
Injection USP, 100 mg/ Inc., Subsidiary of
mL. Teva Pharmaceuticals
USA, Inc.
ANDA 086031......... Isosorbide Dinitrate Do.
Sublingual Tablets USP,
5 mg.
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ANDA 086034......... Isosorbide Dinitrate Do.
Tablets USP, 5 mg.
ANDA 086188......... Gerimal (ergoloid Do.
mesylates) Sublingual
Tablets, 1 mg.
ANDA 086385......... Nandrolone Decanoate Do.
Injection, 50 mg/mL.
ANDA 086562......... Wigraine (ergotamine Organon USA, Inc.,
tartrate and caffeine) Subsidiary of Merck &
Tablets USP, 1 mg/100 Co., Inc., 2000
mg. Galloping Hill Rd.,
Kenilworth, NJ 07033.
ANDA 086742......... Choledyl SA Warner Chilcott Co.,
(oxtriphylline) LLC, Subsidiary of Teva
Extended-Release Pharmaceuticals USA,
Tablets, 600 mg. Inc., 425 Privet Rd.,
Horsham, PA 19044.
ANDA 086863......... Chlorpromazine HCl Oral Actavis Mid Atlantic,
Concentrate USP, 100 mg/ LLC, Subsidiary of Teva
mL. Pharmaceuticals USA,
Inc., 425 Privet Rd.,
Horsham, PA 19044.
ANDA 087233......... Ergoloid Mesylates Watson Laboratories,
Sublingual Tablets USP, Inc., Subsidiary of
0.5 mg. Teva Pharmaceuticals
USA, Inc.
ANDA 087244......... Ergoloid Mesylates Do.
Tablets USP, 1 mg.
ANDA 087318......... Tolbutamide Tablets USP, Do.
500 mg.
ANDA 087727......... Aminophylline Oral Actavis Mid Atlantic,
Solution USP, 105 mg/5 LLC, Subsidiary of Teva
mL (Dye Free). Pharmaceuticals USA,
Inc.
ANDA 088128......... Nandrolone Decanoate Watson Laboratories,
Injection, 200 mg/mL. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 088337......... Ergostat (ergotamine Do.
tartrate) Sublingual
Tablets USP, 2 mg.
ANDA 088477......... Thioridazine HCl Tablets Do.
USP, 15 mg.
ANDA 088561......... Thioridazine HCl Tablets Do.
USP, 10 mg.
ANDA 088564......... Thioridazine HCl Tablets Do.
USP, 100 mg.
ANDA 088724......... Methyclothiazide Tablets Do.
USP, 5 mg.
ANDA 088734......... Meclizine HCl Tablets, Pliva, Inc., Subsidiary
25 mg. of Teva Pharmaceuticals
USA, Inc.
ANDA 088769......... Mepivacaine HCl Watson Laboratories,
Injection USP, 1%. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 088770......... Mepivacaine HCl Do.
Injection USP, 2%.
ANDA 088872......... Thioridazine HCl Tablets Do.
USP, 200 mg.
ANDA 089026......... Procainamide HCl Do.
Extended-Release
Tablets USP, 250 mg.
ANDA 089027......... Procainamide HCl Do.
Extended-Release
Tablets USP, 500 mg.
ANDA 089530......... Prochlorperazine Do.
Edisylate Injection
USP, EQ 5 mg base/mL.
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Therefore, approval of the applications listed in table 1, and all
amendments and supplements thereto, is hereby withdrawn as of February
1, 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 table 1 that
are in inventory on the date that this notice becomes effective (see
DATES) 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: December 26, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-28254 Filed 12-29-17; 8:45 am]
BILLING CODE 4164-01-P
