83 FR 35654 - ICU Medical, Inc., et al.; Withdrawal of Approval of 31 Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 145 (July 27, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 145 (July 27, 2018)
| Page Range | 35654-35655 | |
| FR Document | 2018-16037 |
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)] [Notices] [Pages 35654-35655] From the Federal Register Online [www.thefederalregister.org] [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Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn. DATES: Approval is withdrawn as of August 27, 2018.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
![35654 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
Docket: For access to the docket to drugs or new drug uses intended for Information/default.htm, or https://
read background documents or the slowly progressive, low-prevalence rare www.regulations.gov.
electronic and written/paper comments diseases that are associated with Dated: July 20, 2018.
received, go to https:// substrate deposition and are caused by Leslie Kux,
www.regulations.gov and insert the single enzyme defects. This guidance
Associate Commissioner for Policy.
docket number, found in brackets in the applies only to those low-prevalence
rare diseases with a well-characterized [FR Doc. 2018–16036 Filed 7–26–18; 8:45 am]
heading of this document, into the
‘‘Search’’ box and follow the prompts pathophysiology and in which changes BILLING CODE 4164–01–P
and/or go to the Dockets Management in substrate deposition can be readily
Staff, 5630 Fishers Lane, Rm. 1061, measured in relevant tissue(s).
This draft guidance is being issued DEPARTMENT OF HEALTH AND
Rockville, MD 20852.
You may submit comments on any consistent with FDA’s good guidance HUMAN SERVICES
guidance at any time (see 21 CFR practices regulation (21 CFR 10.115).
Food and Drug Administration
10.115(g)(5)). The draft guidance, when finalized, will
Submit written requests for single represent the current thinking of FDA
copies of the draft guidance to the on providing evidence of effectiveness [Docket No. FDA–2018–N–2493]
Division of Drug Information, Center for for replacement or corrective therapies
intended for slowly progressive, low- ICU Medical, Inc., et al.; Withdrawal of
Drug Evaluation and Research, Food
prevalence rare diseases with substrate Approval of 31 Abbreviated New Drug
and Drug Administration, 10001 New
deposition that results from single Applications
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993– enzyme defects. It does not establish AGENCY: Food and Drug Administration,
0002, or Office of Communication, any rights for any person and is not HHS.
Outreach, and Development, Center for binding on FDA or the public. You can
use an alternative approach if it satisfies ACTION: Notice.
Biologics Evaluation and Research,
Food and Drug Administration, 10903 the requirements of the applicable SUMMARY: The Food and Drug
New Hampshire Ave., Bldg. 71, Rm. statutes and regulations. This guidance Administration (FDA or Agency) is
3128, Silver Spring, MD 20993–0002. is not subject to Executive Order 12866. withdrawing approval of 31 abbreviated
Send one self-addressed adhesive label II. Paperwork Reduction Act of 1995 new drug applications (ANDAs) from
to assist that office in processing your multiple applicants. The holders of the
requests. See the SUPPLEMENTARY This guidance refers to previously
approved collections of information that applications notified the Agency in
INFORMATION section for electronic writing that the drug products were no
are subject to review by the Office of
access to the draft guidance document. longer marketed and requested that the
Management and Budget (OMB) under
FOR FURTHER INFORMATION CONTACT: approval of the applications be
the Paperwork Reduction Act of 1995
Dragos Roman, Center for Drug (44 U.S.C. 3501–3520). The collections withdrawn.
Evaluation and Research, Food and of information in 21 CFR part 312 have DATES: Approval is withdrawn as of
Drug Administration, 10903 New been approved under OMB control August 27, 2018.
Hampshire Ave., Bldg. 22, Rm. 5152, number 0910–0014. The collections of
Silver Spring, MD 20993–0002, 301– FOR FURTHER INFORMATION CONTACT:
information in 21 CFR part 50 have been Trang Tran, Center for Drug Evaluation
796–1285; or Stephen Ripley, Center for approved under OMB control number
Biologics Evaluation and Research, and Research, Food and Drug
0910–0755. The collections of
Food and Drug Administration, 10903 Administration, 10903 New Hampshire
information for expedited programs in
New Hampshire Ave., Bldg. 71, Rm. Ave., Bldg. 75, Rm. 1671, Silver Spring,
the guidance for industry entitled
7301, Silver Spring, MD 20993–0002, MD 20993–0002, 240–402–7945,
‘‘Expedited Programs for Serious
240–402–7911. Trang.Tran@fda.hhs.gov.
Conditions—Drugs and Biologics’’
SUPPLEMENTARY INFORMATION: (available at https://www.fda.gov/ucm/ SUPPLEMENTARY INFORMATION: The
groups/fdagov-public/@fdagov-drugs- holders of the applications listed in the
I. Background table have informed FDA that these drug
gen/documents/document/ucm35
FDA is announcing the availability of 8301.pdf) have been approved under products are no longer marketed and
a draft guidance for industry entitled OMB control number 0910–0765. have requested that FDA withdraw
‘‘Slowly Progressive, Low-Prevalence approval of the applications under the
Rare Diseases with Substrate Deposition III. Electronic Access process described in § 314.150(c) (21
That Results from Single Enzyme Persons with access to the internet CFR 314.150(c)). The applicants have
Defects: Providing Evidence of may obtain the draft guidance at either also, by their requests, waived their
Effectiveness for Replacement or https://www.fda.gov/Drugs/Guidance opportunity for a hearing. Withdrawal
Corrective Therapies.’’ This document is ComplianceRegulatoryInformation/ of approval of an application or
intended to provide guidance to Guidances/default.htm, http:// abbreviated application under
sponsors on the evidence necessary to www.fda.gov/BiologicsBloodVaccines/ § 314.150(c) is without prejudice to
demonstrate the effectiveness of new GuidanceComplianceRegulatory refiling.
Application No. Drug Applicant
amozie on DSK3GDR082PROD with NOTICES1
ANDA 020345 .... Aminosyn-HF (amino acids) Injection, 8% ............................... ICU Medical, Inc., 600 North Field Dr., Lake Forest, IL
60045.
ANDA 040723 .... Isosorbide Dinitrate Extended-Release Tablets USP, 40 milli- Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward,
grams (mg). CA 94544.
ANDA 064062 .... Amphotericin B for Injection USP, 50 mg/vial ......................... Teva Parenteral Medicines, Inc., 19 Hughes, Irvine, CA
92618.
ANDA 064200 .... Cefotaxime for Injection USP, Equivalent to (EQ) 500 mg Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich,
base/vial, EQ 1 gram (g) base/vial, and EQ 2 g base/vial. IL 60047.
VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1](https://thefederalregister.org/doc/83_FR_35799/page/1.svg)
![Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35655
Application No. Drug Applicant
ANDA 064201 .... Cefotaxime for Injection USP, EQ 10 g base/vial and EQ 20 Do.
g base/vial.
ANDA 065251 .... Cefuroxime for Injection USP, EQ 75 g base/bag and EQ Samson Medical Technologies, LLC, 2050 Springdale Rd.,
225 g base/bag (Pharmacy Bulk Package). P.O. Box 2730, Suite 400, Cherry Hill, NJ 08034.
ANDA 070892 .... Metoclopramide Hydrochloride (HCl) Injection, EQ 10 mg Norbrook Laboratories, Ltd., c/o Norbrook, Inc., 9401 Indian
base/2 milliliters (mL). Creek Pkwy., Suite 680, Overland Park, KS 66210.
ANDA 075309 .... Ticlopidine HCl Tablets USP, 250 mg ..................................... Watson Laboratories, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc., 425 Privet Rd., Horsham, PA 19044.
ANDA 076797 .... Risperidone Oral Solution USP, 1 mg/mL ............................... Precision Dose, Inc., 722 Progressive Lane, South Beloit, IL
61080.
ANDA 077656 .... Thrive (nicotine polacrilex) Gum USP (Chewable), EQ 4 mg GlaxoSmithKline Consumer Healthcare, 184 Liberty Corner
base. Rd., Suite 200, Warren, NJ 07059.
ANDA 077658 .... Thrive (nicotine polacrilex) Gum USP (Chewable), EQ 2 mg Do.
base.
ANDA 080188 .... Testosterone Propionate Injection USP, 25 mg/mL, 50 mg/ Watson Laboratories, Inc., Subsidiary of Teva Pharma-
mL, and 100 mg/mL. ceuticals USA, Inc.
ANDA 083398 .... Prednisolone Acetate Injectable Suspension, 25 mg/mL ........ Do.
ANDA 083764 .... Prednisolone Acetate Injectable Suspension, 50 mg/mL ........ Do.
ANDA 084072 .... Triamcinolone Diacetate Injection, 40 mg/mL ......................... Do.
ANDA 084270 .... Triamcinolone Tablets USP, 4 mg ........................................... Do.
ANDA 084466 .... Reserpine and Hydrochlorothiazide Tablets, 0.125 mg/25 mg Do.
ANDA 084604 .... Procainamide HCl Capsules, 250 mg ...................................... Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc.
ANDA 085693 .... Phentermine HCl Tablets USP, 8 mg ...................................... Sandoz, Inc., 4700 Sandoz Dr., Wilson, NC 27893.
ANDA 085863 .... Theophylline Elixir, 80 mg/15 mL ............................................ Precision Dose, Inc.
ANDA 087185 .... Ergoloid Mesylates Sublingual Tablets USP, 1 mg ................. Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharma-
ceuticals USA, Inc.
ANDA 087770 .... Sulfinpyrazone Capsules USP, 200 mg .................................. Do.
ANDA 088648 .... Methotrexate Injection USP, EQ 25 mg base/mL ................... Norbrook Laboratories, Ltd., c/o Norbrook, Inc.
ANDA 088928 .... Chlorzoxazone Tablets USP, 250 mg ..................................... Actavis Elizabeth, LLC, Subsidiary of Teva Pharmaceuticals
USA, Inc.
ANDA 090663 .... Gemcitabine for Injection USP, EQ 200 mg base/vial and EQ Hameln RDS GmbH, c/o B&H Consulting Services, Inc., 50
1 g base/vial. Division St., Suite 206, Somerville, NJ 08876.
ANDA 091469 .... Vancomycin HCl for Injection USP, EQ 10 g base/vial (Phar- Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc.,
macy Bulk Package). 781 Chestnut Ridge Rd., P.O. Box 4310, Morgantown, WV
26504.
ANDA 202390 .... Tramadol HCl Tablets USP, 50 mg ......................................... Accord Healthcare, Inc., 1009 Slater Rd., Suite 210–B, Dur-
ham, NC 27703.
ANDA 203506 .... Oxymorphone HCl Extended-Release Tablets, 5 mg, 7.5 mg, Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical
10 mg, 15 mg, 20 mg, 30 mg, and 40 mg. Industries, Inc., 2 Independence Way, Princeton, NJ
08540.
ANDA 204320 .... Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, Ajanta Pharma, Ltd., c/o Ajanta Pharma USA, Inc., 440 U.S.
15 mg, and 20 mg. Highway 22 East, One Grande Commons, Suite 150,
Bridgewater, NJ 08807.
ANDA 204706 .... Olopatadine HCl Ophthalmic Solution USP, EQ 0.1% base ... Zambon S.p.A., c/o Camargo Pharmaceutical Services, LLC,
9825 Kenwood Rd., Suite 203, Cincinnati, OH 45242.
ANDA 207467 .... Nevirapine Extended-Release Tablets, 100 mg and 400 mg Technology Organized, LLC, 9191 Point Replete Dr., Fort
Belvoir, VA 22060.
Therefore, approval of the Dated: July 23, 2018. ACTION: Notice of availability.
applications listed in the table, and all Leslie Kux,
amendments and supplements thereto, Associate Commissioner for Policy.
SUMMARY: The Food and Drug
is hereby withdrawn as of August 27, Administration (FDA or Agency) is
[FR Doc. 2018–16037 Filed 7–26–18; 8:45 am]
announcing the availability of a final
2018. Introduction or delivery for BILLING CODE 4164–01–P
guidance for industry entitled
introduction into interstate commerce of
‘‘Clarification of Orphan Designation of
products without approved new drug Drugs and Biologics for Pediatric
applications violates section 301(a) and DEPARTMENT OF HEALTH AND
Subpopulations of Common Diseases.’’
(d) of the Federal Food, Drug, and HUMAN SERVICES
FDA does not expect to grant any
Cosmetic Act (21 U.S.C. 331(a) and (d)). additional orphan-drug designation to
Food and Drug Administration
Drug products that are listed in the table drugs for pediatric subpopulations of
that are in inventory on August 27, 2018 common diseases (i.e., diseases or
may continue to be dispensed until the [Docket No. FDA–2017–D–6380]
conditions with an overall prevalence of
amozie on DSK3GDR082PROD with NOTICES1
inventories have been depleted or the Clarification of Orphan Designation of 200,000 or greater). This will help
drug products have reached their Drugs and Biologics for Pediatric resolve an unintended loophole in the
expiration dates or otherwise become Subpopulations of Common Diseases; Pediatric Research Equity Act (PREA)
violative, whichever occurs first. Guidance for Industry; Availability orphan exemption process where a
sponsor holding a pediatric-
AGENCY: Food and Drug Administration, subpopulation designation can submit a
HHS. marketing application for use of its drug
VerDate Sep<11>2014 17:38 Jul 26, 2018 Jkt 244001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\27JYN1.SGM 27JYN1](https://thefederalregister.org/doc/83_FR_35799/page/2.svg)
Document Created: 2018-07-27 04:05:00
Document Modified: 2018-07-27 04:05:00
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Approval is withdrawn as of August 27, 2018. | |
| 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] | |
| FR Citation | 83 FR 35654 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR