35654 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

www.regulations.gov and insert the 

docket number, found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

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copies of the draft guidance to the 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, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist that office in processing your 

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access to the draft guidance document.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a draft guidance for industry entitled 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, http://

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. 

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, 

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. 

Application No. Drug Applicant 

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 milligrams (mg).Impax Laboratories, Inc., 30831 Huntwood Ave., Hayward, 

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 

base/vial, EQ 1 gram (g) base/vial, and EQ 2 g base/vial.

Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, 

IL 60047. 


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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 

g base/vial.

Do. 

ANDA 065251 .... Cefuroxime for Injection USP, EQ 75 g base/bag and EQ 

225 g base/bag (Pharmacy Bulk Package).

Samson Medical Technologies, LLC, 2050 Springdale Rd., 

P.O. Box 2730, Suite 400, Cherry Hill, NJ 08034. 

ANDA 070892 .... Metoclopramide Hydrochloride (HCl) Injection, EQ 10 mg 

base/2 milliliters (mL).

Norbrook Laboratories, Ltd., c/o Norbrook, Inc., 9401 Indian 

Creek Pkwy., Suite 680, Overland Park, KS 66210. 

ANDA 075309 .... Ticlopidine HCl Tablets USP, 250 mg ..................................... Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals 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 

base.

GlaxoSmithKline Consumer Healthcare, 184 Liberty Corner 

Rd., Suite 200, Warren, NJ 07059. 

ANDA 077658 .... Thrive (nicotine polacrilex) Gum USP (Chewable), EQ 2 mg 

base.

Do. 

ANDA 080188 .... Testosterone Propionate Injection USP, 25 mg/mL, 50 mg/ 

mL, and 100 mg/mL.

Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals 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 Pharmaceuticals 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 Pharmaceuticals 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 

1 g base/vial.

Hameln RDS GmbH, c/o B&H Consulting Services, Inc., 50 

Division St., Suite 206, Somerville, NJ 08876. 

ANDA 091469 .... Vancomycin HCl for Injection USP, EQ 10 g base/vial (Pharmacy Bulk Package).Mylan Laboratories, Ltd., c/o Mylan Pharmaceuticals, Inc., 

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, Durham, NC 27703. 

ANDA 203506 .... Oxymorphone HCl Extended-Release Tablets, 5 mg, 7.5 mg, 

10 mg, 15 mg, 20 mg, 30 mg, and 40 mg.

Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical 

Industries, Inc., 2 Independence Way, Princeton, NJ 

08540. 

ANDA 204320 .... Olanzapine Orally Disintegrating Tablets USP, 5 mg, 10 mg, 

15 mg, and 20 mg.

Ajanta Pharma, Ltd., c/o Ajanta Pharma USA, Inc., 440 U.S. 

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 

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 

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 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: 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 


amozie on DSK3GDR082PROD with NOTICES1