Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 20 Abbreviated New Drug Applications, 40070-40071 [2018-17226]
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40070
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
Dated: August 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
ACTION:
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 20 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withdrawn.
SUMMARY:
[FR Doc. 2018–17303 Filed 8–10–18; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2876]
Fougera Pharmaceuticals, Inc., et al.;
Withdrawal of Approval of 20
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Notice.
Approval is withdrawn as of
September 12, 2018.
FOR FURTHER INFORMATION CONTACT:
Trang Tran, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
DATES:
Ave., Bldg. 75, Rm. 1671, Silver Spring,
MD 20993–0002, 240–402–7945,
Trang.Tran@fda.hhs.gov.
The
holders of the applications 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 § 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
§ 314.150(c) is without prejudice to
refiling.
SUPPLEMENTARY INFORMATION:
Drug
Applicant
ANDA 060133 ......................
Chloramphenicol Ophthalmic Ointment, 1% ...................
ANDA 060572 ......................
Mycolog II (nystatin and triamcinolone acetonide) Ointment USP, 100,000 units/gram (g) and 0.1%.
Hydrocortisone Acetate and Neomycin Sulfate Ointment, 0.5%/0.5% and 1.5%/0.5%.
Polycillin (ampicillin) Capsules, 250 milligrams (mg) and
500 mg.
Cap-Profen (ibuprofen) Tablets USP, 200 mg (White) ...
Ibuprofen Tablets, 200 mg (Brown) ................................
Vecuronium Bromide for Injection, 10 mg/vial and 20
mg/vial.
Fougera Pharmaceuticals, Inc., 60 Baylis Rd., P.O. Box
2006, Melville, NY 11747.
Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd.,
P.O. Box 4310, Morgantown, WV 26504.
Fougera Pharmaceuticals, Inc..
ANDA 061107 ......................
sradovich on DSK3GMQ082PROD with NOTICES
ANDA 061988 ......................
ANDA 072097 ......................
ANDA 072098 ......................
ANDA 074334 ......................
ANDA 074874 ......................
VerDate Sep<11>2014
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Pentoxifylline Extended-Release Tablets, 400 mg .........
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Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543.
L. Perrigo Co., 515 Eastern Ave., Allegan, MI 49010.
Do.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA
19044.
Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA,
Inc., 425 Privet Rd., Horsham, PA 19044.
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EN13AU18.010</GPH>
Application No.
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices
40071
Application No.
Drug
Applicant
ANDA 074945 ......................
Atracurium Besylate Injection, 10 mg/milliliter (mL) .......
ANDA 077251 ......................
Finasteride Tablets USP, 5 mg .......................................
ANDA 077983 ......................
ANDA 080425 ......................
Gemcitabine for Injection USP, Equivalent to (EQ) 200
mg base/vial and EQ 1 g/vial.
Texacort (hydrocortisone) Topical Solution, 1% .............
ANDA 083242 ......................
Amen (medroxyprogesterone acetate) Tablets, 10 mg ..
ANDA 085455 ......................
Dexamethasone Tablets USP, 0.25 mg .........................
ANDA 086308 ......................
Homapin-10 (homatropine methylbromide) Tablets
USP, 10 mg.
Homapin-5 (homatropine methylbromide) Tablets USP,
5 mg.
Equipin (homatropine methylbromide) Chewable Tablets, 3 mg.
Beta-2 (isoetharine hydrochloride (HCl)) Inhalation Solution, 1%.
Folicet (folic acid) Tablets USP, 1 mg ............................
Trimethobenzamide HCl Injection, 100 mg/mL ..............
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Gedeon Richter Plc., c/o Gedeon Richter USA, Inc.,
119 Cherry Hill Rd., Suite 325, Parsippany, NJ
07054.
Teva Pharmaceuticals USA, Inc., 425 Privet Rd.,
Horsham, PA 19044.
Mission Pharmacal Co., 10999 IH 10 West, Suite 1000,
San Antonio, TX 78230.
Valeant Pharmaceuticals North America, LLC, 400
Somerset Corporate Blvd., Bridgewater, NJ 08807.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc..
Mission Pharmacal Co.
ANDA 086309 ......................
ANDA 086310 ......................
ANDA 086711 ......................
ANDA 087438 ......................
ANDA 087939 ......................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of September
12, 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 September 12,
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: August 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–17226 Filed 8–10–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
sradovich on DSK3GMQ082PROD with NOTICES
Office of the Director, National
Institutes of Health; Notice of Meeting
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of a
meeting of the Advisory Committee to
the Director, National Institutes of
Health.
The meeting will be held as a
teleconference call only and is open to
the public to dial-in for participation.
Individuals who plan to dial-in to the
meeting and need special assistance or
VerDate Sep<11>2014
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Do.
Do.
Nephron Pharmaceuticals, Corp., 4500 12th St. Extension, West Columbia, SC 20172.
Mission Pharmacal Co.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
other reasonable accommodations in
order to do so, should notify the Contact
Person listed below in advance of the
meeting.
Dated: August 8, 2018.
David D. Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
Name of Committee: Advisory Committee
to the Director, National Institutes of Health.
Date: August 24, 2018.
Time: 9:15 a.m. to 9:45 a.m.
Agenda: Updates on ACD Working Groups.
Place: National Institutes of Health,
Building 1, One Center Drive, Bethesda, MD
20892 (Telephone Conference Call), 800–
369–1915, Access Code: 6496247.
Contact Person: Gretchen Wood, Staff
Assistant, National Institutes of Health,
Office of the Director, One Center Drive,
Building 1, Room 126, Bethesda, MD 20892,
301–496–4272, Woodgs@od.nih.gov.
This notice is being published less than 15
days prior to the meeting due to scheduling
difficulties.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
Information is also available on the
Institute’s/Center’s home page: https://
acd.od.nih.gov, where an agenda and any
additional information for the meeting will
be posted when available.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.14, Intramural Research
Training Award; 93.22, Clinical Research
Loan Repayment Program for Individuals
from Disadvantaged Backgrounds; 93.232,
Loan Repayment Program for Research
Generally; 93.39, Academic Research
Enhancement Award; 93.936, NIH Acquired
Immunodeficiency Syndrome Research Loan
Repayment Program; 93.187, Undergraduate
Scholarship Program for Individuals from
Disadvantaged Backgrounds, National
Institutes of Health, HHS)
[FR Doc. 2018–17345 Filed 8–10–18; 8:45 am]
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BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; National Cancer Institute
(NCI) Future Fellows Resume Databank
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995 to provide
opportunity for public comment on
proposed data collection projects, the
National Institutes of Health, National
Cancer Institute (NCI) will publish
periodic summaries of propose projects
to be submitted to the Office of
Management and Budget (OMB) for
review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
FOR FURTHER INFORMATION CONTACT: To
obtain a copy of the data collection
plans and instruments, submit
comments in writing, or request more
information on the proposed project,
contact: Angela Jones, Program
SUMMARY:
E:\FR\FM\13AUN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 156 (Monday, August 13, 2018)]
[Notices]
[Pages 40070-40071]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17226]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2876]
Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of
20 Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 20 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 September 12, 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 holders of the applications 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.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
ANDA 060133................. Chloramphenicol Fougera
Ophthalmic Pharmaceuticals,
Ointment, 1%. Inc., 60 Baylis
Rd., P.O. Box 2006,
Melville, NY 11747.
ANDA 060572................. Mycolog II (nystatin Mylan
and triamcinolone Pharmaceuticals,
acetonide) Ointment Inc., 781 Chestnut
USP, 100,000 units/ Ridge Rd., P.O. Box
gram (g) and 0.1%. 4310, Morgantown,
WV 26504.
ANDA 061107................. Hydrocortisone Fougera
Acetate and Pharmaceuticals,
Neomycin Sulfate Inc..
Ointment,
0.5%[hairsp]/
[hairsp]0.5% and
1.5%[hairsp]/
[hairsp]0.5%.
ANDA 061988................. Polycillin Bristol-Myers Squibb
(ampicillin) Co., P.O. Box 4000,
Capsules, 250 Princeton, NJ
milligrams (mg) and 08543.
500 mg.
ANDA 072097................. Cap-Profen L. Perrigo Co., 515
(ibuprofen) Tablets Eastern Ave.,
USP, 200 mg (White). Allegan, MI 49010.
ANDA 072098................. Ibuprofen Tablets, Do.
200 mg (Brown).
ANDA 074334................. Vecuronium Bromide Watson Laboratories,
for Injection, 10 Inc., Subsidiary of
mg/vial and 20 mg/ Teva
vial. Pharmaceuticals
USA, Inc., 425
Privet Rd.,
Horsham, PA 19044.
ANDA 074874................. Pentoxifylline Pliva, Inc.,
Extended-Release Subsidiary of Teva
Tablets, 400 mg. Pharmaceuticals
USA, Inc., 425
Privet Rd.,
Horsham, PA 19044.
[[Page 40071]]
ANDA 074945................. Atracurium Besylate Watson Laboratories,
Injection, 10 mg/ Inc., Subsidiary of
milliliter (mL). Teva
Pharmaceuticals
USA, Inc.
ANDA 077251................. Finasteride Tablets Gedeon Richter Plc.,
USP, 5 mg. c/o Gedeon Richter
USA, Inc., 119
Cherry Hill Rd.,
Suite 325,
Parsippany, NJ
07054.
ANDA 077983................. Gemcitabine for Teva Pharmaceuticals
Injection USP, USA, Inc., 425
Equivalent to (EQ) Privet Rd.,
200 mg base/vial Horsham, PA 19044.
and EQ 1 g/vial.
ANDA 080425................. Texacort Mission Pharmacal
(hydrocortisone) Co., 10999 IH 10
Topical Solution, West, Suite 1000,
1%. San Antonio, TX
78230.
ANDA 083242................. Amen Valeant
(medroxyprogesteron Pharmaceuticals
e acetate) Tablets, North America, LLC,
10 mg. 400 Somerset
Corporate Blvd.,
Bridgewater, NJ
08807.
ANDA 085455................. Dexamethasone Watson Laboratories,
Tablets USP, 0.25 Inc., Subsidiary of
mg. Teva
Pharmaceuticals
USA, Inc..
ANDA 086308................. Homapin-10 Mission Pharmacal
(homatropine Co.
methylbromide)
Tablets USP, 10 mg.
ANDA 086309................. Homapin-5 Do.
(homatropine
methylbromide)
Tablets USP, 5 mg.
ANDA 086310................. Equipin (homatropine Do.
methylbromide)
Chewable Tablets, 3
mg.
ANDA 086711................. Beta-2 (isoetharine Nephron
hydrochloride Pharmaceuticals,
(HCl)) Inhalation Corp., 4500 12th
Solution, 1%. St. Extension, West
Columbia, SC 20172.
ANDA 087438................. Folicet (folic acid) Mission Pharmacal
Tablets USP, 1 mg. Co.
ANDA 087939................. Trimethobenzamide Watson Laboratories,
HCl Injection, 100 Inc., Subsidiary of
mg/mL. Teva
Pharmaceuticals
USA, Inc.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
September 12, 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 September 12, 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: August 7, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-17226 Filed 8-10-18; 8:45 am]
BILLING CODE 4164-01-P
