Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 32305 

collections of information in 21 CFR 

part 58 have been approved under OMB 

control number 0910–0119; 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 601 have been approved under 

OMB control number 0910–0338; the 

collections of information in the 

guidance entitled ‘‘Expedited Programs 

for Serious Conditions—Drugs and 

Biologics’’ have been approved under 

OMB control number 0910–0765; and 

the collections of information in the 

guidance entitled ‘‘Formal Meetings 

Between the FDA and Sponsors or 

Applicants’’ have been approved under 

OMB control number 0910–0429. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or https://

www.regulations.gov. 

Dated: July 5, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14871 Filed 7–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2180] 

Concordia Pharmaceuticals, Inc., et al.; 

Withdrawal of Approval of 29 New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of 29 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withdrawn. 

DATES: Approval is withdrawn as of 

August 13, 2018. 

FOR FURTHER INFORMATION CONTACT: 

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. 

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 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 

NDA 011287 ......... Kayexalate (sodium polystyrene sulfonate) Powder for Suspension, 

453.6 gram (g)/bottle.

Concordia Pharmaceuticals, Inc., c/o Mapi USA, Inc., 2343 Alexandria 

Dr., Lexington, KY 40504. 

NDA 012249 ......... Librium (chlordiazepoxide hydrochloride (HCl)) Capsules, 5 milligram 

(mg), 10 mg, and 25 mg.

Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate Blvd., Bridgewater, NJ 08807. 

NDA 016211 ......... Miochol (acetylcholine chloride) for Ophthalmic Solution, 20 mg/vial .... Novartis Pharmaceuticals Corp., One Health Pl., East Hanover, NJ 

07936. 

NDA 018674 ......... Metro I.V. (metronidazole) Injection, 500 mg/100 milliliter (mL) ............. B. Braun Medical, Inc., 901 Marcon Blvd., Allentown, PA 18109. 

NDA 018852 ......... Sulfamethoxazole and Trimethoprim Tablets USP, 400 mg; 80 mg ...... Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, 

Inc., 425 Privet Rd., Horsham, PA 19044. 

NDA 018854 ......... Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg; 160 mg .... Do. 

NDA 018988 ......... Vasocidin (prednisolone sodium phosphate and sulfacetamide sodium) 

Ophthalmic Solution, equivalent to (EQ) 0.23% phosphate/10%.

Novartis Pharmaceuticals Corp. 

NDA 019844 ......... Isolyte H in Dextrose 5% in Plastic Container Injection ......................... B. Braun Medical, Inc. 

NDA 019870 ......... Isolyte M in Dextrose 5% in Plastic Container Injection ......................... Do. 

NDA 019964 ......... Terazol 3 (terconazole) Vaginal Cream, 0.8% ........................................ Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton Rd., 

Titusville, NJ 08560. 

NDA 020000 ......... Dextrose 5% in Ringer’s in Plastic Container Injection .......................... B. Braun Medical, Inc. 

NDA 020393 ......... Atrovent (ipratropium bromide) Nasal Spray, 0.021 mg/spray ............... Boehringer Ingelheim Pharmaceuticals, Inc., 900 Ridgebury Rd., P.O. 

Box 368, Ridgefield, CT 06877–0368. 

NDA 020394 ......... Atrovent (ipratropium bromide) Nasal Spray, 0.042 mg/spray ............... Do. 

NDA 021180 ......... Ortho Evra (ethinyl estradiol; norelgestromin) Transdermal Patch, 

0.035 mg/24 h; 0.15 mg/24 h.

Janssen Pharmaceuticals, Inc., 1000 U.S. Route 202, P.O. Box 300, 

Raritan, NJ 08869–0602. 

NDA 021633 ......... Femtrace (estradiol acetate) Tablets, 0.45 mg, 0.9 mg, and 1.8 mg ..... Allergan Pharmaceuticals International, Ltd., c/o Allergan Sales, LLC, 

2525 Dupont Dr., Irvine, CA 92612. 

NDA 022033 ......... Luvox CR (fluvoxamine maleate) Extended-Release Capsules, 100 mg 

and 150 mg.

Jazz Pharmaceuticals, Inc., 3180 Porter Dr., Palo Alto, CA 94304. 

NDA 022106 ......... Doribax (doripenem) for Injection, 250 mg/vial and 500 mg/vial ............ Shionogi, Inc., 300 Campus Dr., Florham Park, NJ 07932. 

NDA 022386 ......... PrandiMet (metformin HCl; repaglinide) Tablets, 500mg; 1 mg and 500 

mg; 2 mg.

Novo Nordisk, Inc., P.O. Box 846, Plainsboro, NJ 08536. 

NDA 050201 ......... Ophthocort (chloramphenicol, hydrocortisone acetate, polymyxin B sulfate) Ophthalmic Ointment USP, 10 mg/g; 5 mg/g; 10,000 units/g.Parkedale Pharmaceuticals, Subsidiary of Pfizer Inc., 235 East 42nd 

St., New York, NY 10017. 

NDA 050344 ......... Statrol (neomycin sulfate; polymyxin B sulfate) Ophthalmic Ointment, 

EQ 3.5 mg base/g; 10,000 units/g.

Alcon Laboratories, Inc., 6201 South Freeway, TC–45, Fort Worth, TX 

76134. 

NDA 050442 ......... Vibramycin (doxycycline hyclate) Injection, EQ to 200 mg base/vial 

and EQ 100 mg base/vial.

Pfizer, Inc., 235 East 42nd St., New York, NY 10017. 

NDA 050497 ......... Ticar (ticarcillin disodium) Injection, EQ 1 g base/vial, EQ 3 g base/ 

vial, EQ 6 g base/vial, EQ 20 g base/vial, and EQ 30 g base/vial.

GlaxoSmithKline, 1250 Collegeville Rd., Collegeville, PA 19426. 

NDA 050512 ......... Duricef (cefadroxil monohydrate) USP Capsules, EQ 500 mg base and 

EQ 250 mg base.

Warner Chilcott Co., LLC, 100 Enterprise Dr., Rockaway, NJ 07866. 

NDA 050527 ......... Duricef (cefadroxil monohydrate) USP For Oral Suspension, EQ 125 

mg base/5 mL, EQ 250 mg base/5 mL, and EQ 500 mg base/5 mL.

Do. 

NDA 050593 ......... Eryc Sprinkles (erythromycin) Capsules, 125 mg ................................... Hospira Inc., 275 North Field Dr., Lake Forest, IL 60045. 

NDA 050646 ......... Ceptaz (ceftazidime) Injection, 500 mg/vial, 1 g/vial, 2 g/vial, and 10 g/ 

vial.

GlaxoSmithKline. 

NDA 050668 ......... Lorabid (loracarbef) Capsules USP, 200 mg and 400 mg ..................... King Pharmaceuticals, Inc., 501 Fifth St., Bristol, TN 37620. 

NDA 050792 ......... Cefotaxime and Dextrose 2.4% in Plastic Container, EQ 2 g base, and 

Cefotaxime and Dextrose 3.9% in Plastic Container, EQ 1 g base.

B. Braun Medical, Inc. 


amozie on DSK3GDR082PROD with NOTICES1
32306 Federal Register / Vol. 83, No. 134 / Thursday, July 12, 2018 / Notices 

Application No. Drug Applicant 

NDA 050807 ......... Epirubicin HCl for Injection, 50 mg/vial, 200 mg/vial .............................. Hospira, Inc. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of August 13, 

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 13, 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 9, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14935 Filed 7–11–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA 2018–D–2238] 

Human Gene Therapy for Hemophilia; 

Draft 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 draft 

document entitled ‘‘Human Gene 

Therapy for Hemophilia; Draft Guidance 

for Industry.’’ The draft guidance 

document provides recommendations to 

stakeholders developing human gene 

therapy (GT) products for the treatment 

of hemophilia. The draft guidance 

provides recommendations on the 

clinical trial design and related 

development of coagulation factor VIII 

(hemophilia A) and IX (hemophilia B) 

activity assays, including how to 

address discrepancies in factor VIII and 

factor IX activity assays. The draft 

guidance also includes 

recommendations regarding preclinical 

considerations to support development 

of GT products for the treatment of 

hemophilia. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 10, 2018 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

Electronic Submissions 

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 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand Delivery/Courier (for 

Written/Paper Submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment as 

well as any attachments, except for 

information submitted, marked, and 

identified as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA 2018– 

D–2238 for ‘‘Human Gene Therapy for 

Hemophilia; Draft Guidance for 

Industry.’’ Received comments will be 

placed in the docket and, except for 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday. 

• Confidential Submissions—To 

submit a comment with confidential 

information that you do not wish to be 

made publicly available, submit your 

comments only as a written/paper 

submission. You should submit two 

copies, total. One copy will include the 

information you claim to be confidential 

with a heading or cover note that states 

‘‘THIS DOCUMENT CONTAINS 

CONFIDENTIAL INFORMATION.’’ The 

Agency will review this copy, including 

the claimed confidential information, in 

its consideration of comments. The 

second copy, which will have the 

claimed confidential information 

redacted/blacked out, will be available 

for public viewing and posted on 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. If you do not wish your name and 

contact information to be made publicly 

available, you can provide this 

information on the cover sheet and not 

in the body of your comments, and you 

must identify this information as 

‘‘confidential.’’ Any information marked 

as ‘‘confidential’’ will not be disclosed 

except in accordance with 21 CFR 10.20 

and other applicable disclosure law. For 

more information about FDA’s posting 

of comments to public dockets, see 80 

FR 56469, September 18, 2015, or access 

the information at: https://www.gpo.gov/ 

fdsys/pkg/FR-2015-09-18/pdf/2015- 

23389.pdf. 

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 Office 

of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), 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 the office in processing your 

requests. The draft guidance may also be 

obtained by mail by calling CBER at 1– 


amozie on DSK3GDR082PROD with NOTICES1