40070 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 

Dated: August 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17303 Filed 8–10–18; 8:45 am] 

BILLING CODE 4164–01–C 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2876] 

Fougera Pharmaceuticals, Inc., et al.; 

Withdrawal of Approval of 20 

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 20 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withdrawn. 

DATES: Approval is withdrawn as of 

September 12, 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 060133 ...................... Chloramphenicol Ophthalmic Ointment, 1% ................... Fougera Pharmaceuticals, Inc., 60 Baylis Rd., P.O. Box 

2006, Melville, NY 11747. 

ANDA 060572 ...................... Mycolog II (nystatin and triamcinolone acetonide) Ointment USP, 100,000 units/gram (g) and 0.1%.Mylan Pharmaceuticals, Inc., 781 Chestnut Ridge Rd., 

P.O. Box 4310, Morgantown, WV 26504. 

ANDA 061107 ...................... Hydrocortisone Acetate and Neomycin Sulfate Ointment, 0.5%/0.5% and 1.5%/0.5%.Fougera Pharmaceuticals, Inc.. 

ANDA 061988 ...................... Polycillin (ampicillin) Capsules, 250 milligrams (mg) and 

500 mg.

Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ 

08543. 

ANDA 072097 ...................... Cap-Profen (ibuprofen) Tablets USP, 200 mg (White) ... L. Perrigo Co., 515 Eastern Ave., Allegan, MI 49010. 

ANDA 072098 ...................... Ibuprofen Tablets, 200 mg (Brown) ................................ Do. 

ANDA 074334 ...................... Vecuronium Bromide for Injection, 10 mg/vial and 20 

mg/vial.

Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc., 425 Privet Rd., Horsham, PA 

19044. 

ANDA 074874 ...................... Pentoxifylline Extended-Release Tablets, 400 mg ......... Pliva, Inc., Subsidiary of Teva Pharmaceuticals USA, 

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


sradovich on DSK3GMQ082PROD with NOTICESEN13AU18.010</GPH>
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40071 

Application No. Drug Applicant 

ANDA 074945 ...................... Atracurium Besylate Injection, 10 mg/milliliter (mL) ....... Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. 

ANDA 077251 ...................... Finasteride Tablets USP, 5 mg ....................................... Gedeon Richter Plc., c/o Gedeon Richter USA, Inc., 

119 Cherry Hill Rd., Suite 325, Parsippany, NJ 

07054. 

ANDA 077983 ...................... Gemcitabine for Injection USP, Equivalent to (EQ) 200 

mg base/vial and EQ 1 g/vial.

Teva Pharmaceuticals USA, Inc., 425 Privet Rd., 

Horsham, PA 19044. 

ANDA 080425 ...................... Texacort (hydrocortisone) Topical Solution, 1% ............. Mission Pharmacal Co., 10999 IH 10 West, Suite 1000, 

San Antonio, TX 78230. 

ANDA 083242 ...................... Amen (medroxyprogesterone acetate) Tablets, 10 mg .. Valeant Pharmaceuticals North America, LLC, 400 

Somerset Corporate Blvd., Bridgewater, NJ 08807. 

ANDA 085455 ...................... Dexamethasone Tablets USP, 0.25 mg ......................... Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc.. 

ANDA 086308 ...................... Homapin-10 (homatropine methylbromide) Tablets 

USP, 10 mg.

Mission Pharmacal Co. 

ANDA 086309 ...................... Homapin-5 (homatropine methylbromide) Tablets USP, 

5 mg.

Do. 

ANDA 086310 ...................... Equipin (homatropine methylbromide) Chewable Tablets, 3 mg.Do. 

ANDA 086711 ...................... Beta-2 (isoetharine hydrochloride (HCl)) Inhalation Solution, 1%.Nephron Pharmaceuticals, Corp., 4500 12th St. Extension, West Columbia, SC 20172. 

ANDA 087438 ...................... Folicet (folic acid) Tablets USP, 1 mg ............................ Mission Pharmacal Co. 

ANDA 087939 ...................... Trimethobenzamide HCl Injection, 100 mg/mL .............. Watson Laboratories, Inc., Subsidiary of Teva Pharmaceuticals USA, Inc. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of September 

12, 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 September 12, 

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: August 7, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17226 Filed 8–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Office of the Director, National 

Institutes of Health; Notice of Meeting 

Pursuant to section 10(a) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of a 

meeting of the Advisory Committee to 

the Director, National Institutes of 

Health. 

The meeting will be held as a 

teleconference call only and is open to 

the public to dial-in for participation. 

Individuals who plan to dial-in to the 

meeting and need special assistance or 

other reasonable accommodations in 

order to do so, should notify the Contact 

Person listed below in advance of the 

meeting. 

Name of Committee: Advisory Committee 

to the Director, National Institutes of Health. 

Date: August 24, 2018. 

Time: 9:15 a.m. to 9:45 a.m. 

Agenda: Updates on ACD Working Groups. 

Place: National Institutes of Health, 

Building 1, One Center Drive, Bethesda, MD 

20892 (Telephone Conference Call), 800– 

369–1915, Access Code: 6496247. 

Contact Person: Gretchen Wood, Staff 

Assistant, National Institutes of Health, 

Office of the Director, One Center Drive, 

Building 1, Room 126, Bethesda, MD 20892, 

301–496–4272, Woodgs@od.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to scheduling 

difficulties. 

Any interested person may file written 

comments with the committee by forwarding 

the statement to the Contact Person listed on 

this notice. The statement should include the 

name, address, telephone number and when 

applicable, the business or professional 

affiliation of the interested person. 

Information is also available on the 

Institute’s/Center’s home page: http://

acd.od.nih.gov, where an agenda and any 

additional information for the meeting will 

be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.14, Intramural Research 

Training Award; 93.22, Clinical Research 

Loan Repayment Program for Individuals 

from Disadvantaged Backgrounds; 93.232, 

Loan Repayment Program for Research 

Generally; 93.39, Academic Research 

Enhancement Award; 93.936, NIH Acquired 

Immunodeficiency Syndrome Research Loan 

Repayment Program; 93.187, Undergraduate 

Scholarship Program for Individuals from 

Disadvantaged Backgrounds, National 

Institutes of Health, HHS) 

Dated: August 8, 2018. 

David D. Clary, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2018–17345 Filed 8–10–18; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Proposed Collection; 60-Day Comment 

Request; National Cancer Institute 

(NCI) Future Fellows Resume Databank 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: In compliance with the 

requirement of the Paperwork 

Reduction Act of 1995 to provide 

opportunity for public comment on 

proposed data collection projects, the 

National Institutes of Health, National 

Cancer Institute (NCI) will publish 

periodic summaries of propose projects 

to be submitted to the Office of 

Management and Budget (OMB) for 

review and approval. 

DATES: Comments regarding this 

information collection are best assured 

of having their full effect if received 

within 60 days of the date of this 

publication. 

FOR FURTHER INFORMATION CONTACT: To 

obtain a copy of the data collection 

plans and instruments, submit 

comments in writing, or request more 

information on the proposed project, 

contact: Angela Jones, Program 


sradovich on DSK3GMQ082PROD with NOTICES