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 


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35656 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 

in the non-orphan adult population of 

that disease, get a pediatricsubpopulation designation for the 

pediatric subset of the disease, and, due 

to this designation, be exempt from 

conducting the pediatric studies 

normally required under PREA when 

seeking approval of the adult indication. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on July 27, 2018. 

ADDRESSES: You may submit either 

electronic or written comments on 

Agency guidances 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– 

2017–D–6380 for ‘‘Clarification of 

Orphan Designation of Drugs and 

Biologics for Pediatric Subpopulations 

of Common Diseases.’’ 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 this guidance to the Office of 

Orphan Products Development, Office 

of the Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5295, Silver Spring, 

MD 20993. Send one self-addressed 

adhesive label to assist that office in 

processing your requests. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Aaron Friedman, Office of Orphan 

Products Development, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, Rm. 5209, Silver Spring, 

MD 20993, 301–796–2989. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA 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.’’ 

In the Federal Register of December 20, 

2017 (82 FR 60402), FDA published a 

notice of availability for the draft 

guidance entitled ‘‘Clarification of 

Orphan Designation of Drugs and 

Biologics for Pediatric Subpopulations 

of Common Diseases,’’ announcing that 

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 

over 200,000 in the United States). In 

the Federal Register of January 12, 2018 

(83 FR 1619), FDA announced that it 

was extending the comment period for 

this draft guidance for an additional 30 

days. FDA received several comments 

on the draft guidance and those 

comments were considered as the 

guidance was finalized. The guidance 

announced in this notice finalizes the 

draft guidance dated December 2017. 

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 

in the non-orphan adult population of 

that disease, get a pediatricsubpopulation designation for the 

pediatric subset of the disease, and, due 

to this designation, be exempt from 

conducting the pediatric studies 

normally required under PREA when 

seeking approval of the adult indication. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on orphan designation 

of drugs and biologics for pediatric 

subpopulations of common diseases. It 

does not establish any rights for any 

person and is not binding on FDA or the 


amozie on DSK3GDR082PROD with NOTICES1
Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35657 

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. Electronic Access 

Persons with access to the internet 

may obtain the guidance at either 

https://www.fda.gov/Orphan or https://

www.regulations.gov. 

Dated: July 23, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16027 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–D–2478] 

Recommendations for Reducing the 

Risk of Transfusion-Transmitted 

Babesiosis; 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 ‘‘Recommendations 

for Reducing the Risk of TransfusionTransmitted Babesiosis; Draft Guidance 

for Industry.’’ The draft guidance 

document notifies blood establishments 

that collect blood and blood 

components that we have determined 

babesiosis to be a relevant transfusiontransmitted infection (RTTI) and 

provides recommendations for donor 

screening, donation testing, donor 

deferral, and product management to 

reduce the risk of transfusiontransmitted babesiosis (TTB). The 

recommendations contained in the 

guidance apply to the collection of 

blood and blood components, except 

Source Plasma. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by September 25, 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–2478 for ‘‘Recommendations 

for Reducing the Risk of TransfusionTransmitted Babesiosis; 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– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

FOR FURTHER INFORMATION CONTACT: 

Valerie A. Butler, 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 document entitled 

‘‘Recommendations for Reducing the 

Risk of Transfusion-Transmitted 

Babesiosis; Draft Guidance for 

Industry.’’ The draft guidance document 


amozie on DSK3GDR082PROD with NOTICES1