Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46081 

Application No. Drug Applicant 

ANDA 074801 ......................... Ketorolac Tromethamine Injection USP, 15 mg/mL and 30 

mg/mL.

Do. 

ANDA 075385 ......................... Buspirone HCl Tablets USP, 5 mg, 10 mg, and 15 mg ..... Ivax Pharmaceuticals, Inc., Subsidiary of Teva Pharmaceuticals USA, 

Inc. 

ANDA 075453 ......................... Doxazosin Tablets USP, EQ 1 mg base, EQ 2 mg base, 

EQ 4 mg base, and EQ 8 mg base.

Do. 

ANDA 076883 ......................... Sotalol HCl Tablets USP, 80 mg, 120 mg, and 160 mg .... Teva Pharmaceuticals USA, Inc. 

ANDA 077052 ......................... Citalopram Hydrobromide Tablets, EQ 10 mg base, EQ 

20 mg base, and EQ 40 mg base.

Sun Pharmaceutical Industries, Inc. 

ANDA 077937 ......................... Meloxicam Tablets, 7.5 mg and 15 mg .............................. Do. 

ANDA 078081 ......................... Amlodipine Besylate Tablets, EQ 2.5 mg base, EQ 5 mg 

base, and EQ 10 mg base.

Do. 

ANDA 078158 ......................... Fosphenytoin Sodium Injection USP, EQ 50 mg Phenytoin Soudium/mL.Hospira, Inc. 

ANDA 078483 ......................... Zolpidem Tartrate Extended-Release Tablets USP, 6.25 

mg and 12.5 mg.

Synthon Pharmaceuticals, Inc., 1007 Slater Rd., Suite 150, Durham, NC 

27703. 

ANDA 080136 ......................... Isoniazid Tablets, 100 mg ................................................... Sun Pharmaceutical Industries, Inc. 

ANDA 080209 ......................... Prednisone Tablets USP, 5 mg .......................................... Contract Pharmacal Corp., c/o SciRegs International Inc., 6333 

Summercrest Dr., Columbia, MD 21045. 

ANDA 080224 ......................... Sorbitol; Mannitol Irrigation Solution, 2.7 g/100 mL; 540 

mg/100 mL.

Hospira, Inc. 

ANDA 083345 ......................... Potassium Chloride for Injection Concentrate USP, 1 

milliequivalent (mEQ)/mL, 1.5 mEQ/mL, and 2 mEQ/mL.

Do. 

ANDA 083808 ......................... Quinidine Sulfate Tablets USP, 200 mg ............................. Contract Pharmacal Corp., c/o SciRegs International Inc. 

ANDA 084623 ......................... Chlordiazepoxide HCl Capsules USP, 10 mg .................... Upsher-Smith Laboratories, Inc., 6701 Evenstad Dr., Maple Grove, MN 

55369. 

ANDA 084644 ......................... Chlordiazepoxide HCl Capsules USP, 5 mg ...................... Do. 

ANDA 084710 ......................... Ogen (estropipate) Vaginal Cream USP, 1.5 mg/g ............ Pfizer Inc. 

ANDA 085061 ......................... Folic Acid Tablets USP, 1 mg ............................................ Contract Pharmacal Corp., c/o SciRegs International Inc. 

ANDA 085933 ......................... Phentermine HCl Tablets USP ........................................... Lemmon Co., 650 Cathill Rd., Sellersville, PA 18960. 

ANDA 086494 ......................... Chlordiazepoxide HCl Capsules, 25 mg ............................. Teva Pharmaceuticals USA, Inc. 

ANDA 086821 ......................... Hydroxyzine HCl Injection USP, 50 mg/mL ........................ Hospira, Inc. 

ANDA 087416 ......................... Hydroxyzine HCl Injection USP, 25 mg/mL, Carpuject ...... Do. 

ANDA 087546 ......................... Hydroxyzine HCl Injection USP, 50 mg/mL, Carpuject ...... Do. 

ANDA 087862 ......................... Hydroxyzine HCl Tablets USP, 100 mg ............................. Sun Pharmaceutical Industries, Inc. 

ANDA 088147 ......................... Aminophylline in Sodium Chloride 0.45% Injection, 100 

mg/100 mL and 200 mg/100 mL.

Hospira, Inc. 

ANDA 088367 ......................... Lidocaine HCl Injection USP, 10% ..................................... Do. 

ANDA 088542 ......................... Lidocaine HCl Injection USP, 4% ....................................... Do. 

ANDA 089162 ......................... Cyclopentolate HCl Ophthalmic Solution, 1% .................... Alcon Pharmaceuticals, Ltd., 6201 South Freeway TC–45, Fort Worth, 

TX 76134. 

ANDA 089347 ......................... Diatrizoate Meglumine and Diatrizoate Sodium Injection 

USP, 66%; 10%.

Bracco Diagnostics Inc., 259 Prospect Plains Rd., Bldg. H, Monroe 

Township, NJ 08831. 

ANDA 089393 ......................... Glycopyrrolate Injection USP, 0.2 mg/mL .......................... Hospira, Inc. 

ANDA 089488 ......................... Diphenhydramine HCl Capsules, 25 mg ............................ Sun Pharmaceutical Industries, Inc. 

ANDA 089521 ......................... Phenytoin Sodium Injection USP, 50 mg/mL, Ampule ....... Hospira, Inc. 

ANDA 089537 ......................... Procainamide HCl Injection USP, 500 mg/mL, Carpuject .. Do. 

ANDA 089744 ......................... Phenytoin Sodium Injection USP, 50 mg/mL, Carpuject .... Do. 

ANDA 089915 ......................... Leucovorin Calcium for Injection, EQ 100 mg base/vial .... Pharmachemie B.V., c/o SICOR Pharmaceuticals, Inc., 19 Hughes, 

Irvine, CA 92618. 

NDA 202258 ........................... Victrelis (boceprevir) Capsules, 200 mg ............................. Merck Sharp & Dohme Corp., Subsidiary of Merck & Company, Inc., 1 

Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889. 

NDA 203093 ........................... Vitekta (elvitegravir) Tablets, 85 mg and 150 mg .............. Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn, effective 

November 2, 2017. 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 the date that this 

notice becomes effective (see DATES) 

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: September 27, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21177 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–4977] 

Joint Meeting of the 

Psychopharmacologic Drugs Advisory 

Committee and the Drug Safety and 

Risk Management Advisory 

Committee; Notice of Meeting; 

Establishment of a Public Docket; 

Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; establishment of a 

public docket; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
46082 Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 

advisory committee meeting of the 

Psychopharmacologic Drugs Advisory 

Committee and the Drug Safety and Risk 

Management Advisory Committee. The 

general function of the committees is to 

provide advice and recommendations to 

the Agency on FDA’s regulatory issues. 

The meeting will be open to the public. 

FDA is establishing a docket for public 

comment on this document. 

DATES: The public meeting will be held 

on October 31, 2017, from 8 a.m. to 5 

p.m. 

ADDRESSES: FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Answers to commonly asked questions 

including information regarding special 

accommodations due to a disability, 

visitor parking, and transportation may 

be accessed at: https://www.fda.gov/

AdvisoryCommittees/AboutAdvisory

Committees/ucm408555.htm. 

FDA is establishing a docket for 

public comment on this meeting. The 

docket number is FDA–2017–N–4977. 

The docket will close on October 27, 

2017. Submit either electronic or 

written comments on this public 

meeting by October 27, 2017. Late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before October 27, 

2017. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of October 27, 2017. 

Comments received by mail/hand 

delivery/courier (for written/paper 

submissions) will be considered timely 

if they are postmarked or the delivery 

service acceptance receipt is on or 

before that date. 

Comments received on or before 

October 17, 2017, will be provided to 

the committees. Comments received 

after that date will be taken into 

consideration by the Agency. 

You may submit comments 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–N–4977 for 

‘‘Psychopharmacologic Drugs Advisory 

Committee and the Drug Safety and Risk 

Management Advisory Committee; 

Notice of Meeting; Establishment of a 

Public Docket; Request for Comments.’’ 

Received comments, those filed in a 

timely manner (see ADDRESSES), 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 office 

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. 

FOR FURTHER INFORMATION CONTACT: 

Kalyani Bhatt, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, Rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, Fax: 301–847–8533, email: 

kalyani.bhatt@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at https://www.fda.

gov/AdvisoryCommittees/default.htm 

and scroll down to the appropriate 

advisory committee meeting link, or call 

the advisory committee information line 

to learn about possible modifications 

before coming to the meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The committees will discuss 

new drug application (NDA) 209819, 

buprenorphine subcutaneous injection, 

submitted by Indivior Pharmaceuticals, 

Inc., for treatment of opioid 

dependence. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at https://www.fda.gov/


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 190 / Tuesday, October 3, 2017 / Notices 46083 

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committees. All electronic 

and written submissions submitted to 

the Docket (see ADDRESSES) on or before 

October 17, 2017, will be provided to 

the committees. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 p.m. Those 

individuals interested in making formal 

oral presentations should notify the 

contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before October 6, 2017. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by October 10, 2017. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require special accommodations 

due to a disability, please contact 

Kalyani Bhatt at least 7 days in advance 

of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

https://www.fda.gov/Advisory

Committees/AboutAdvisoryCommittees/

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 27, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21170 Filed 10–2–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–N–0502] 

Range of Risk Evaluation and 

Mitigation Strategies Platform 

Standards Initiative: Needs 

Assessment; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) is 

seeking public input on the design of 

the REMS Platform Standards Initiative, 

as well as methods and best practices 

for its construction. To facilitate this, 

FDA is making available the ‘‘REMS 

Platform Standards Initiative: Needs 

Assessment’’ (needs assessment), which 

summarizes a range of risk evaluation 

and mitigation strategies (REMS) 

activities that could be standardized and 

integrated into the health care system 

through the use of electronic data 

standards. 

DATES: The comment period will be 

open indefinitely. 

ADDRESSES: You may submit comments 

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– 

2013–N–0502 for ‘‘REMS Platform 

Standards Initiative: Needs Assessment; 

Request for Comments.’’ 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 


asabaliauskas on DSKBBXCHB2PROD with NOTICES