Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of 27 Abbreviated New Drug Applications, 39102-39103 [2018-16985]
Download as PDF
<![CDATA[
39102
Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices
Jeffrey M. Zirger,
Acting Chief, Information Collection Review
Office, Office of Scientific Integrity, Office
of the Associate Director for Science, Office
of the Director, Centers for Disease Control
and Prevention.
[FR Doc. 2018–16947 Filed 8–7–18; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2485]
Fougera Pharmaceuticals, Inc., et al.;
Withdrawal of Approval of 27
Abbreviated New Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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:
The Food and Drug
Administration (FDA or Agency) 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withdrawn.
DATES: Approval is withdrawn as of
September 7, 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,
Trang.Tran@fda.hhs.gov.
SUMMARY:
Application No.
Drug
Applicant
ANDA 061467 .........
Pyocidin-Otic (hydrocortisone and polymyxin B sulfate) Otic Solution, 5 milligrams (mg)/10,000 units per milliliter (mL).
ANDA 061653 .........
Tetrex (tetracycline phosphate complex) Capsules, Equivalent to (EQ) 100 mg
Hydrochloride (HCl), EQ 250 mg HCl and EQ 500 mg HCl.
Bristacycline (tetracycline HCl) Capsules, 250 mg and 500 mg ...........................
Penicillin V Potassium Tablets ..............................................................................
Ampicillin Capsules, 250 mg and 500 mg .............................................................
Azotrex (phenazopyridine HCl, sulfamethizole and tetracycline phosphate complex) Capsules, 50 mg/250 mg/125 mg.
Hetacillin Potassium ...............................................................................................
Bristamycin (erythromycin stearate) Tablets, EQ 250 mg base ...........................
Bristacycline (tetracycline HCl) Capsules, 250 mg and 500 mg ...........................
Tetrex (tetracycline phosphate complex) Capsules, EQ 250 mg HCl and EQ
500 mg HCl.
Azotrex (phenazopyridine HCl, sulfamethizole, and tetracycline) Capsules, 50
mg/250 mg/125 mg.
Tetrex-S (tetracycline) Syrup, 125 mg/5 mL .........................................................
Cephradine Powder for Injection ...........................................................................
Cephradine Tablets ................................................................................................
Amphotericin B for Use in Parenteral Products ....................................................
Mycolog (nystatin, neomycin sulfate, gramicidin, and triamcinolone acetonide)
Ointment.
Foamcoat (aluminum hydroxide; magnesium trisilicate) Chewable Tablets, 80
mg/20 mg (OTC).
Nuprin (ibuprofen) Tablets, 200 mg .......................................................................
Nuprin (ibuprofen) Tablets, 200 mg .......................................................................
Phrenilin with Caffeine and Codeine (acetaminophen, butalbital, caffeine, and
codeine phosphate) Capsules, 325 mg/50 mg/40 mg/30 mg.
Fougera Pharmaceuticals, Inc., 60
Baylis Rd., P.O. Box 2006, Melville,
NY 11747.
Bristol-Myers Squibb Co., P.O. Box
4000, Princeton, NJ 08543.
Do.
Do.
Do.
Do.
ANDA
ANDA
ANDA
ANDA
061658
061711
061721
061726
.........
.........
.........
.........
ANDA
ANDA
ANDA
ANDA
061790
061887
061888
061889
.........
.........
.........
.........
ANDA 061890 .........
ANDA
ANDA
ANDA
ANDA
ANDA
061891
061975
062168
062259
062543
.........
.........
.........
.........
.........
ANDA 071793 .........
ANDA 072035 .........
ANDA 072036 .........
ANDA 074911 .........
ANDA 074944 .........
Atracurium Besylate Injection, 10 mg/mL ..............................................................
ANDA 075206 .........
ANDA 077930 .........
Cytosar-U (cytarabine) for Injection USP, 100 mg/vial, 500 mg/vial, 1 gram (g)/
vial, and 2 g/vial.
Rosiglitazone Maleate and Metformin HCl Tablets, EQ 1 mg base/500 mg, EQ
2 mg base/500 mg, EQ 4 mg base/500 mg, EQ 2 mg base/1 g, and EQ 4 mg
base/1 g.
Meloxicam Tablets, 7.5 mg and 15 mg .................................................................
ANDA 080658 .........
Procaine HCl Injection, 1% and 2% ......................................................................
ANDA 083128 .........
ANDA 090181 .........
Hydrocortisone Acetate Injectable Suspension, 25 mg/mL ...................................
Ifosfamide for Injection, 1 g/20 mL and 3 g/60 mL ...............................................
sradovich on DSK3GMQ082PROD with NOTICES
ANDA 077337 .........
VerDate Sep<11>2014
22:37 Aug 07, 2018
Jkt 244001
PO 00000
Frm 00062
Fmt 4703
Sfmt 4703
E:\FR\FM\08AUN1.SGM
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Do.
Guardian Drug Co., 2 Charles Court,
Dayton, NJ 08810.
Bristol-Myers Squibb Co.
Do.
Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate
Blvd., Bridgewater, NJ 08807.
Watson Laboratories, Inc., Subsidiary
of Teva Pharmaceuticals USA, Inc.,
425 Privet Rd., Horsham, PA 19044.
Teva Pharmaceuticals USA, Inc., 425
Privet Rd., Horsham, PA 19044.
Do.
Impax
Laboratories,
Inc.,
30831
Huntwood Ave., Hayward, CA 94544.
Watson Laboratories, Inc., Subsidiary
of Teva Pharmaceuticals USA, Inc.
Do.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047.
08AUN1
Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of September 7,
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 7,
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 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16985 Filed 8–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2018–N–2702]
Merck Sharp & Dohme Corporation, et
al.; Withdrawal of Approval of Four
New Drug Applications
Food and Drug Administration,
HHS.
ACTION:
Approval is withdrawn as of
September 7, 2018.
DATES:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
AGENCY:
39103
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of four new drug
applications (NDAs) 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:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6248,
Silver Spring, MD 20993–0002, 301–
796–3601.
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:
Application No.
Drug
Applicant
NDA 005619 ............
Aminohippurate Sodium (PAH) 20% sterile solution Injection, 2 grams in 10 milliliter (mL) vials.
NDA 008506 ............
Hydrocortone (hydrocortisone) Tablets USP, 10 milligrams
(mg) and 20 mg.
Durabolin (nandrolone phenpropionate) Injection, 25 mg/mL
and 50 mg/mL.
Ortho-Cept (desogestrel and ethinyl estradiol) Tablets USP,
0.15 mg/0.03 mg (21-Day and 28-Day Regimens).
Merck Sharp & Dohme Corp., Subsidiary of Merck & Company, Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889.
Do.
NDA 011891 ............
NDA 020301 ............
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of September 7,
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 7,
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 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
sradovich on DSK3GMQ082PROD with NOTICES
[FR Doc. 2018–16982 Filed 8–7–18; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
22:37 Aug 07, 2018
Jkt 244001
Organon USA, Inc., Subsidiary of Merck & Company, Inc.,
2000 Galloping Hill Rd., Kenilworth, NJ 07033.
Janssen Pharmaceuticals, Inc., 920 U.S. Hwy. 202, P.O.
Box 300, Raritan, NJ 08869–0602.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–1692]
Elemental Impurities in Drug Products;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Electronic Submissions
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Elemental Impurities in Drug
Products.’’ This guidance finalizes the
draft guidance issued July 1, 2016,
which provides recommendations
regarding the control of elemental
impurities of human drug products
marketed in the United States consistent
with the implementation of
International Council for Harmonisation
(ICH) guidance for industry entitled
‘‘Q3D Elemental Impurities’’ (ICH Q3D).
This guidance will also assist
manufacturers of compendial drug
products in responding to the issuance
of the United States Pharmacopeia
SUMMARY:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
(USP) requirement for the control of
elemental impurities.
DATES: The announcement of the
guidance is published in the Federal
Register on August 8, 2018.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
E:\FR\FM\08AUN1.SGM
08AUN1
]]>Agencies
[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Pages 39102-39103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16985]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2485]
Fougera Pharmaceuticals, Inc., et al.; Withdrawal of Approval of
27 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 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: Approval is withdrawn as of September 7, 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 061467................... Pyocidin-Otic Fougera
(hydrocortisone and Pharmaceuticals
polymyxin B sulfate) , Inc., 60
Otic Solution, 5 Baylis Rd.,
milligrams (mg)/ P.O. Box 2006,
10,000 units per Melville, NY
milliliter (mL). 11747.
ANDA 061653................... Tetrex (tetracycline Bristol-Myers
phosphate complex) Squibb Co.,
Capsules, Equivalent P.O. Box 4000,
to (EQ) 100 mg Princeton, NJ
Hydrochloride (HCl), 08543.
EQ 250 mg HCl and EQ
500 mg HCl.
ANDA 061658................... Bristacycline Do.
(tetracycline HCl)
Capsules, 250 mg and
500 mg.
ANDA 061711................... Penicillin V Potassium Do.
Tablets.
ANDA 061721................... Ampicillin Capsules, Do.
250 mg and 500 mg.
ANDA 061726................... Azotrex Do.
(phenazopyridine HCl,
sulfamethizole and
tetracycline
phosphate complex)
Capsules, 50 mg/250
mg/125 mg.
ANDA 061790................... Hetacillin Potassium.. Do.
ANDA 061887................... Bristamycin Do.
(erythromycin
stearate) Tablets, EQ
250 mg base.
ANDA 061888................... Bristacycline Do.
(tetracycline HCl)
Capsules, 250 mg and
500 mg.
ANDA 061889................... Tetrex (tetracycline Do.
phosphate complex)
Capsules, EQ 250 mg
HCl and EQ 500 mg HCl.
ANDA 061890................... Azotrex Do.
(phenazopyridine HCl,
sulfamethizole, and
tetracycline)
Capsules, 50 mg/250
mg/125 mg.
ANDA 061891................... Tetrex-S Do.
(tetracycline) Syrup,
125 mg/5 mL.
ANDA 061975................... Cephradine Powder for Do.
Injection.
ANDA 062168................... Cephradine Tablets.... Do.
ANDA 062259................... Amphotericin B for Use Do.
in Parenteral
Products.
ANDA 062543................... Mycolog (nystatin, Do.
neomycin sulfate,
gramicidin, and
triamcinolone
acetonide) Ointment.
ANDA 071793................... Foamcoat (aluminum Guardian Drug
hydroxide; magnesium Co., 2 Charles
trisilicate) Chewable Court, Dayton,
Tablets, 80 mg/20 mg NJ 08810.
(OTC).
ANDA 072035................... Nuprin (ibuprofen) Bristol-Myers
Tablets, 200 mg. Squibb Co.
ANDA 072036................... Nuprin (ibuprofen) Do.
Tablets, 200 mg.
ANDA 074911................... Phrenilin with Valeant
Caffeine and Codeine Pharmaceuticals
(acetaminophen, North America,
butalbital, caffeine, LLC, 400
and codeine Somerset
phosphate) Capsules, Corporate
325 mg/50 mg/40 mg/30 Blvd.,
mg. Bridgewater, NJ
08807.
ANDA 074944................... Atracurium Besylate Watson
Injection, 10 mg/mL. Laboratories,
Inc.,
Subsidiary of
Teva
Pharmaceuticals
USA, Inc., 425
Privet Rd.,
Horsham, PA
19044.
ANDA 075206................... Cytosar-U (cytarabine) Teva
for Injection USP, Pharmaceuticals
100 mg/vial, 500 mg/ USA, Inc., 425
vial, 1 gram (g)/ Privet Rd.,
vial, and 2 g/vial. Horsham, PA
19044.
ANDA 077337................... Rosiglitazone Maleate Do.
and Metformin HCl
Tablets, EQ 1 mg base/
500 mg, EQ 2 mg base/
500 mg, EQ 4 mg base/
500 mg, EQ 2 mg base/
1 g, and EQ 4 mg base/
1 g.
ANDA 077930................... Meloxicam Tablets, 7.5 Impax
mg and 15 mg. Laboratories,
Inc., 30831
Huntwood Ave.,
Hayward, CA
94544.
ANDA 080658................... Procaine HCl Watson
Injection, 1% and 2%. Laboratories,
Inc.,
Subsidiary of
Teva
Pharmaceuticals
USA, Inc.
ANDA 083128................... Hydrocortisone Acetate Do.
Injectable
Suspension, 25 mg/mL.
ANDA 090181................... Ifosfamide for Fresenius Kabi
Injection, 1 g/20 mL USA, LLC, Three
and 3 g/60 mL. Corporate Dr.,
Lake Zurich, IL
60047.
------------------------------------------------------------------------
[[Page 39103]]
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
September 7, 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 7, 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 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16985 Filed 8-7-18; 8:45 am]
BILLING CODE 4164-01-P
