Watson Laboratories, Inc., and Barr Laboratories, Inc., Subsidiaries of Teva Pharmaceuticals USA, Inc.; Withdrawal of Approval of 54 Abbreviated New Drug Applications, 49214-49215 [2017-23046]
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49214
Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices
Dated: October 19, 2017.
G. Matthew Warren,
Director, Office of Scientific Integrity.
ACTION:
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withdrawn.
BILLING CODE 4164–01–P
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
Food and Drug Administration,
HHS.
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 § 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 § 314.150(c) is
without prejudice to refiling.
SUPPLEMENTARY INFORMATION:
SUMMARY:
[FR Doc. 2017–23019 Filed 10–23–17; 8:45 am]
AGENCY:
Notice.
Approval is withdrawn as of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.
DATES:
TABLE 1
Application No.
Drug
Applicant
ANDA 061717 ........
Doxycycline Hyclate Capsules USP, Equivalent to (EQ) 50 milligrams
(mg) base and EQ 100 mg base.
ANDA 062087 ........
ANDA 062318 ........
ANDA 062994 ........
ANDA 062999 ........
Erythromycin Estolate Capsules USP, EQ 250 mg base .........................
Gentamicin Injection USP, EQ 10 mg base/milliliter (mL) and EQ 40 mg
base/mL.
Ampicillin for 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.
Ampicillin for Injection USP, EQ 10 g base/vial ........................................
Erythromycin Delayed-Release Tablets USP, 500 mg .............................
Watson Laboratories, Inc., Subsidiary of Teva
Pharmaceuticals USA, Inc., 425 Privet Rd.,
Horsham, PA 19044.
Do.
Do.
ANDA 064036 ........
Cefuroxime for Injection USP, EQ 7.5 g base/vial ...................................
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
Diazepam Injection USP, 5 mg/mL ...........................................................
Furosemide Tablets USP, 20 mg ..............................................................
Ibuprofen Tablets USP, 200 mg ...............................................................
Ibuprofen Tablets USP, 400 mg ...............................................................
Ibuprofen Tablets USP, 600 mg ...............................................................
Furosemide Tablets USP, 20 mg ..............................................................
Furosemide Tablets USP, 40 mg ..............................................................
Tolazamide Tablets USP, 500 mg ............................................................
Furosemide Tablets USP, 80 mg ..............................................................
Doxepin Hydrochloride (HCl) Capsules USP, EQ 50 mg base ................
Ibuprofen Tablets USP, 800 mg ...............................................................
Diazepam Injection USP, 5 mg/mL ...........................................................
Fenoprofen Calcium Tablets USP, EQ 600 mg base ...............................
Fenoprofen Calcium Tablets USP, EQ 600 mg base ...............................
Albuterol Tablets USP, EQ 4 mg base .....................................................
Baclofen Tablets USP, 20 mg ...................................................................
Metaproterenol Sulfate Tablets USP, 10 mg ............................................
Meperidine HCl Injection USP, 100 mg/mL ..............................................
Guanabenz Acetate Tablets USP, EQ 4 mg base and EQ 8 mg base ...
Dobutamine Injection USP, EQ 12.5 mg base/mL ...................................
Naproxen Tablets USP, 250 mg, 375 mg, and 500 mg ...........................
Piroxicam Capsules USP, 10 mg and 20 mg ...........................................
Pentamidine Isethionate for Injection, 300 mg/vial ...................................
Pindolol Tablets USP, 5 mg and 10 mg ...................................................
Alprazolam Tablets USP, 0.25 mg, 0.5 mg, and 1 mg .............................
Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg ..............
Diphenhydramine HCl Capsules USP, 25 mg ..........................................
Dexamethasone Tablets USP, 0.75 mg ...................................................
Chlorzoxazone Tablets USP, 500 mg .......................................................
Hydroxyzine HCl Tablets USP, 10 mg ......................................................
Hydrochlorothiazide Tablets USP, 25 mg .................................................
Estropipate Tablets USP, 6 mg ................................................................
Hydrochlorothiazide Tablets USP, 50 mg .................................................
asabaliauskas on DSKBBXCHB2PROD with NOTICES
ANDA 062816 ........
070296
070412
070435
070436
070437
070449
070450
070515
070528
071238
071547
072397
072407
072602
072630
072825
073013
073445
074025
074114
074163
074287
074303
074437
074456
077643
080728
080968
081040
081149
081189
081216
083232
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17:47 Oct 23, 2017
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Barr Laboratories, Inc., Subsidiary of Teva
Pharmaceuticals USA, Inc., 425 Privet Rd.,
Horsham, PA 19044.
Watson Laboratories, Inc., Subsidiary of Teva
Pharmaceuticals USA, Inc.
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E:\FR\FM\24OCN1.SGM
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Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices
49215
TABLE 1—Continued
Application No.
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
085720
085721
085778
086096
086189
086598
086795
087183
087296
087521
087772
087979
088030
089042
........
........
........
........
........
........
........
........
........
........
........
........
........
........
Drug
Meprobamate Tablets USP, 200 mg ........................................................
Meprobamate Tablets USP, 400 mg ........................................................
Hydroxyzine HCl Injection USP, 25 mg/mL ..............................................
Chlorpheniramine Maleate Injection USP, 10 mg/mL ...............................
Ergoloid Mesylates Sublingual Tablets USP, 0.5 mg ...............................
Nandrolone Decanoate Injection USP, 100 mg/mL ..................................
Chlorothiazide Tablets USP, 250 mg ........................................................
Ergoloid Mesylates Sublingual Tablets USP, 1 mg ..................................
Chlorthalidone Tablets USP, 25 mg .........................................................
Chlorthalidone Tablets USP, 50 mg .........................................................
Prednisone Tablets USP, 50 mg ..............................................................
Chloroquine Phosphate Tablets USP, EQ 150 mg base .........................
Chloroquine Phosphate Tablets USP, EQ 300 mg base .........................
Procainamide HCl 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
BILLING CODE 4140–01–P
asabaliauskas on DSKBBXCHB2PROD with NOTICES
National Institute of Allergy and
Infectious Diseases; Notice of Closed
Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
Jkt 244001
Name of Committee: National Institute of
Allergy and Infectious Diseases Special
Emphasis Panel; NIAID SBIR Phase II
Clinical Trial Implementation Cooperative
Agreement (U44).
Date: November 17, 2017.
Time: 1:00 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 5601
Fishers Lane, Rockville, MD 20892
(Telephone Conference Call).
Contact Person: Vasundhara Varthakavi,
Ph.D., DVM, Scientific Review Officer,
Scientific Review Program, Division of
Extramural Activities, Room 3E70, National
Institutes of Health, NIAID, 5601 Fishers
Lane, MSC 9823, Bethesda, MD 20892–9823,
(240) 669–5020, varthakaviv@niaid.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.855, Allergy, Immunology,
and Transplantation Research; 93.856,
Microbiology and Infectious Diseases
Research, National Institutes of Health, HHS)
[FR Doc. 2017–22967 Filed 10–23–17; 8:45 am]
National Institutes of Health
17:47 Oct 23, 2017
would constitute a clearly unwarranted
invasion of personal privacy.
Dated: October 18, 2017.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
Applicant
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
Do.
Do.
Do.
Do.
Do.
Do.
Do.
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Do.
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Do.
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
International Research Ethics Training.
Date: November 16, 2017.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892.
Contact Person: Karin F. Helmers, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3148,
MSC 7770, Bethesda, MD 20892, (301) 254–
9975, helmersk@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; PAR16–121
Early-Stage Preclinical Validation of
Therapeutic Leads for Diseases of Interest to
the NIDDK (R01).
Date: November 16, 2017.
Time: 12:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: Raul Rojas, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6185,
Bethesda, MD 20892, (301) 451–6319, rojasr@
mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Macromolecular Structure and
Function.
Date: November 20, 2017.
Time: 1:00 p.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: C-L Albert Wang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
E:\FR\FM\24OCN1.SGM
24OCN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
