ICU Medical, Inc., et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications, 35654-35655 [2018-16037]
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Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
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You may submit comments on any
guidance at any time (see 21 CFR
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Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002, or Office of Communication,
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Send one self-addressed adhesive label
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requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Dragos Roman, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 5152,
Silver Spring, MD 20993–0002, 301–
796–1285; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993–0002,
240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Slowly Progressive, Low-Prevalence
Rare Diseases with Substrate Deposition
That Results from Single Enzyme
Defects: Providing Evidence of
Effectiveness for Replacement or
Corrective Therapies.’’ This document is
intended to provide guidance to
sponsors on the evidence necessary to
demonstrate the effectiveness of new
drugs or new drug uses intended for
slowly progressive, low-prevalence rare
diseases that are associated with
substrate deposition and are caused by
single enzyme defects. This guidance
applies only to those low-prevalence
rare diseases with a well-characterized
pathophysiology and in which changes
in substrate deposition can be readily
measured in relevant tissue(s).
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on providing evidence of effectiveness
for replacement or corrective therapies
intended for slowly progressive, lowprevalence rare diseases with substrate
deposition that results from single
enzyme defects. It does not establish
any rights for any person and is not
binding on FDA or the public. You can
use an alternative approach if it satisfies
the requirements of the applicable
statutes and regulations. This guidance
is not subject to Executive Order 12866.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014. The collections of
information in 21 CFR part 50 have been
approved under OMB control number
0910–0755. The collections of
information for expedited programs in
the guidance for industry entitled
‘‘Expedited Programs for Serious
Conditions—Drugs and Biologics’’
(available at https://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-drugsgen/documents/document/ucm35
8301.pdf) have been approved under
OMB control number 0910–0765.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://
www.regulations.gov.
Dated: July 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–16036 Filed 7–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–2493]
ICU Medical, Inc., et al.; Withdrawal of
Approval of 31 Abbreviated New Drug
Applications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 31 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:
Approval is withdrawn as of
August 27, 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.
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 § 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.
DATES:
amozie on DSK3GDR082PROD with NOTICES1
Application No.
Drug
Applicant
ANDA 020345 ....
Aminosyn-HF (amino acids) Injection, 8% ...............................
ANDA 040723 ....
Isosorbide Dinitrate Extended-Release Tablets USP, 40 milligrams (mg).
Amphotericin B for Injection USP, 50 mg/vial .........................
ICU Medical, Inc., 600 North Field Dr., Lake Forest, IL
60045.
Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward,
CA 94544.
Teva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA
92618.
Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
IL 60047.
ANDA 064062 ....
ANDA 064200 ....
VerDate Sep<11>2014
Cefotaxime for Injection USP, Equivalent to (EQ) 500 mg
base/vial, EQ 1 gram (g) base/vial, and EQ 2 g base/vial.
17:38 Jul 26, 2018
Jkt 244001
PO 00000
Frm 00051
Fmt 4703
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E:\FR\FM\27JYN1.SGM
27JYN1
Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
Application No.
Drug
ANDA 064201 ....
ANDA 075309 ....
Cefotaxime for Injection USP, EQ 10 g base/vial and EQ 20
g base/vial.
Cefuroxime for Injection USP, EQ 75 g base/bag and EQ
225 g base/bag (Pharmacy Bulk Package).
Metoclopramide Hydrochloride (HCl) Injection, EQ 10 mg
base/2 milliliters (mL).
Ticlopidine HCl Tablets USP, 250 mg .....................................
ANDA 076797 ....
Risperidone Oral Solution USP, 1 mg/mL ...............................
ANDA 077656 ....
....
....
....
....
....
....
Thrive (nicotine polacrilex) Gum USP (Chewable), EQ 4 mg
base.
Thrive (nicotine polacrilex) Gum USP (Chewable), EQ 2 mg
base.
Testosterone Propionate Injection USP, 25 mg/mL, 50 mg/
mL, and 100 mg/mL.
Prednisolone Acetate Injectable Suspension, 25 mg/mL ........
Prednisolone Acetate Injectable Suspension, 50 mg/mL ........
Triamcinolone Diacetate Injection, 40 mg/mL .........................
Triamcinolone Tablets USP, 4 mg ...........................................
Reserpine and Hydrochlorothiazide Tablets, 0.125 mg/25 mg
Procainamide HCl Capsules, 250 mg ......................................
ANDA 085693 ....
ANDA 085863 ....
ANDA 087185 ....
Phentermine HCl Tablets USP, 8 mg ......................................
Theophylline Elixir, 80 mg/15 mL ............................................
Ergoloid Mesylates Sublingual Tablets USP, 1 mg .................
ANDA 087770 ....
ANDA 088648 ....
ANDA 088928 ....
Sulfinpyrazone Capsules USP, 200 mg ..................................
Methotrexate Injection USP, EQ 25 mg base/mL ...................
Chlorzoxazone Tablets USP, 250 mg .....................................
ANDA 090663 ....
Gemcitabine for Injection USP, EQ 200 mg base/vial and EQ
1 g base/vial.
Vancomycin HCl for Injection USP, EQ 10 g base/vial (Pharmacy Bulk Package).
ANDA 065251 ....
ANDA 070892 ....
ANDA 077658 ....
ANDA 080188 ....
ANDA
ANDA
ANDA
ANDA
ANDA
ANDA
083398
083764
084072
084270
084466
084604
ANDA 091469 ....
Applicant
Tramadol HCl Tablets USP, 50 mg .........................................
ANDA 203506 ....
Oxymorphone HCl Extended-Release Tablets, 5 mg, 7.5 mg,
10 mg, 15 mg, 20 mg, 30 mg, and 40 mg.
ANDA 204320 ....
Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg,
15 mg, and 20 mg.
ANDA 204706 ....
Olopatadine HCl Ophthalmic Solution USP, EQ 0.1% base ...
ANDA 207467 ....
amozie on DSK3GDR082PROD with NOTICES1
ANDA 202390 ....
Nevirapine Extended-Release Tablets, 100 mg and 400 mg
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of August 27,
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 August 27, 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.
17:38 Jul 26, 2018
Jkt 244001
Samson Medical Technologies, LLC, 2050 Springdale Rd.,
P.O. Box 2730, Suite 400, Cherry Hill, NJ 08034.
Norbrook Laboratories, Ltd., c/o Norbrook, Inc., 9401 Indian
Creek Pkwy., Suite 680, Overland Park, KS 66210.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
Precision Dose, Inc., 722 Progressive Lane, South Beloit, IL
61080.
GlaxoSmithKline Consumer Healthcare, 184 Liberty Corner
Rd., Suite 200, Warren, NJ 07059.
Do.
Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Do.
Do.
Do.
Do.
Do.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Sandoz, Inc., 4700 Sandoz Dr., Wilson, NC 27893.
Precision Dose, Inc.
Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.
Do.
Norbrook Laboratories, Ltd., c/o Norbrook, Inc.
Actavis Elizabeth, LLC, Subsidiary of Teva Pharmaceuticals
USA, Inc.
Hameln RDS GmbH, c/o B&H Consulting Services, Inc., 50
Division St., Suite 206, Somerville, NJ 08876.
Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc.,
781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV
26504.
Accord Healthcare, Inc., 1009 Slater Rd., Suite 210–B, Durham, NC 27703.
Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical
Industries, Inc., 2 Independence Way, Princeton, NJ
08540.
Ajanta Pharma, Ltd., c/o Ajanta Pharma USA, Inc., 440 U.S.
Highway 22 East, One Grande Commons, Suite 150,
Bridgewater, NJ 08807.
Zambon S.p.A., c/o Camargo Pharmaceutical Services, LLC,
9825 Kenwood Rd., Suite 203, Cincinnati, OH 45242.
Technology Organized, LLC, 9191 Point Replete Dr., Fort
Belvoir, VA 22060.
[FR Doc. 2018–16037 Filed 7–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–6380]
Clarification of Orphan Designation of
Drugs and Biologics for Pediatric
Subpopulations of Common Diseases;
Guidance for Industry; Availability
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
Do.
Dated: July 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
AGENCY:
PO 00000
35655
Frm 00052
Fmt 4703
Sfmt 4703
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a final
guidance for industry entitled
‘‘Clarification of Orphan Designation of
Drugs and Biologics for Pediatric
Subpopulations of Common Diseases.’’
FDA does not expect to grant any
additional orphan-drug designation to
drugs for pediatric subpopulations of
common diseases (i.e., diseases or
conditions with an overall prevalence of
200,000 or greater). This will help
resolve an unintended loophole in the
Pediatric Research Equity Act (PREA)
orphan exemption process where a
sponsor holding a pediatricsubpopulation designation can submit a
marketing application for use of its drug
SUMMARY:
E:\FR\FM\27JYN1.SGM
27JYN1
]]>Agencies
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)]
[Notices]
[Pages 35654-35655]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16037]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-N-2493]
ICU Medical, Inc., et al.; Withdrawal of Approval of 31
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 31 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 August 27, 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 020345............ Aminosyn-HF (amino ICU Medical, Inc., 600
acids) Injection, 8%. North Field Dr., Lake
Forest, IL 60045.
ANDA 040723............ Isosorbide Dinitrate Impax Laboratories,
Extended-Release Inc., 30831 Huntwood
Tablets USP, 40 Ave., Hayward, CA
milligrams (mg). 94544.
ANDA 064062............ Amphotericin B for Teva Parenteral
Injection USP, 50 mg/ Medicines, Inc., 19
vial. Hughes, Irvine, CA
92618.
ANDA 064200............ Cefotaxime for Fresenius Kabi USA,
Injection USP, LLC, Three Corporate
Equivalent to (EQ) 500 Dr., Lake Zurich, IL
mg base/vial, EQ 1 60047.
gram (g) base/vial,
and EQ 2 g base/vial.
[[Page 35655]]
ANDA 064201............ Cefotaxime for Do.
Injection USP, EQ 10 g
base/vial and EQ 20 g
base/vial.
ANDA 065251............ Cefuroxime for Samson Medical
Injection USP, EQ 75 g Technologies, LLC,
base/bag and EQ 225 g 2050 Springdale Rd.,
base/bag (Pharmacy P.O. Box 2730, Suite
Bulk Package). 400, Cherry Hill, NJ
08034.
ANDA 070892............ Metoclopramide Norbrook Laboratories,
Hydrochloride (HCl) Ltd., c/o Norbrook,
Injection, EQ 10 mg Inc., 9401 Indian
base/2 milliliters Creek Pkwy., Suite
(mL). 680, Overland Park,
KS 66210.
ANDA 075309............ Ticlopidine HCl Tablets Watson Laboratories,
USP, 250 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc., 425 Privet
Rd., Horsham, PA
19044.
ANDA 076797............ Risperidone Oral Precision Dose, Inc.,
Solution USP, 1 mg/mL. 722 Progressive Lane,
South Beloit, IL
61080.
ANDA 077656............ Thrive (nicotine GlaxoSmithKline
polacrilex) Gum USP Consumer Healthcare,
(Chewable), EQ 4 mg 184 Liberty Corner
base. Rd., Suite 200,
Warren, NJ 07059.
ANDA 077658............ Thrive (nicotine Do.
polacrilex) Gum USP
(Chewable), EQ 2 mg
base.
ANDA 080188............ Testosterone Propionate Watson Laboratories,
Injection USP, 25 mg/ Inc., Subsidiary of
mL, 50 mg/mL, and 100 Teva Pharmaceuticals
mg/mL. USA, Inc.
ANDA 083398............ Prednisolone Acetate Do.
Injectable Suspension,
25 mg/mL.
ANDA 083764............ Prednisolone Acetate Do.
Injectable Suspension,
50 mg/mL.
ANDA 084072............ Triamcinolone Diacetate Do.
Injection, 40 mg/mL.
ANDA 084270............ Triamcinolone Tablets Do.
USP, 4 mg.
ANDA 084466............ Reserpine and Do.
Hydrochlorothiazide
Tablets, 0.125 mg/25
mg.
ANDA 084604............ Procainamide HCl Ivax Pharmaceuticals,
Capsules, 250 mg. Inc., Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 085693............ Phentermine HCl Tablets Sandoz, Inc., 4700
USP, 8 mg. Sandoz Dr., Wilson,
NC 27893.
ANDA 085863............ Theophylline Elixir, 80 Precision Dose, Inc.
mg/15 mL.
ANDA 087185............ Ergoloid Mesylates Ivax Pharmaceuticals,
Sublingual Tablets Inc., Subsidiary of
USP, 1 mg. Teva Pharmaceuticals
USA, Inc.
ANDA 087770............ Sulfinpyrazone Capsules Do.
USP, 200 mg.
ANDA 088648............ Methotrexate Injection Norbrook Laboratories,
USP, EQ 25 mg base/mL. Ltd., c/o Norbrook,
Inc.
ANDA 088928............ Chlorzoxazone Tablets Actavis Elizabeth,
USP, 250 mg. LLC, Subsidiary of
Teva Pharmaceuticals
USA, Inc.
ANDA 090663............ Gemcitabine for Hameln RDS GmbH, c/o
Injection USP, EQ 200 B&H Consulting
mg base/vial and EQ 1 Services, Inc., 50
g base/vial. Division St., Suite
206, Somerville, NJ
08876.
ANDA 091469............ Vancomycin HCl for Mylan Laboratories,
Injection USP, EQ 10 g Ltd., c/o Mylan
base/vial (Pharmacy Pharmaceuticals,
Bulk Package). Inc., 781 Chestnut
Ridge Rd., P.O. Box
4310, Morgantown, WV
26504.
ANDA 202390............ Tramadol HCl Tablets Accord Healthcare,
USP, 50 mg. Inc., 1009 Slater
Rd., Suite 210-B,
Durham, NC 27703.
ANDA 203506............ Oxymorphone HCl Sun Pharmaceutical
Extended-Release Industries, Ltd., c/o
Tablets, 5 mg, 7.5 mg, Sun Pharmaceutical
10 mg, 15 mg, 20 mg, Industries, Inc., 2
30 mg, and 40 mg. Independence Way,
Princeton, NJ 08540.
ANDA 204320............ Olanzapine Orally Ajanta Pharma, Ltd., c/
Disintegrating Tablets o Ajanta Pharma USA,
USP, 5 mg, 10 mg, 15 Inc., 440 U.S.
mg, and 20 mg. Highway 22 East, One
Grande Commons, Suite
150, Bridgewater, NJ
08807.
ANDA 204706............ Olopatadine HCl Zambon S.p.A., c/o
Ophthalmic Solution Camargo
USP, EQ 0.1% base. Pharmaceutical
Services, LLC, 9825
Kenwood Rd., Suite
203, Cincinnati, OH
45242.
ANDA 207467............ Nevirapine Extended- Technology Organized,
Release Tablets, 100 LLC, 9191 Point
mg and 400 mg. Replete Dr., Fort
Belvoir, VA 22060.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
August 27, 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 August 27, 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: July 23, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16037 Filed 7-26-18; 8:45 am]
BILLING CODE 4164-01-P
