49214 Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices 

Dated: October 19, 2017. 

G. Matthew Warren, 

Director, Office of Scientific Integrity. 

[FR Doc. 2017–23019 Filed 10–23–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5715] 

Watson Laboratories, Inc., and Barr 

Laboratories, Inc., Subsidiaries of Teva 

Pharmaceuticals USA, Inc.; Withdrawal 

of Approval of 54 Abbreviated New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of 54 abbreviated new drug 

applications (ANDAs) from two 

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withdrawn. 

DATES: Approval is withdrawn as of 

November 24, 2017. 

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. 

SUPPLEMENTARY INFORMATION: The 

holders of the applications listed in 

table 1 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 abbreviated 

application under § 314.150(c) is 

without prejudice to refiling. 

TABLE 1 

Application No. Drug Applicant 

ANDA 061717 ........ Doxycycline Hyclate Capsules USP, Equivalent to (EQ) 50 milligrams 

(mg) base and EQ 100 mg base.

Watson Laboratories, Inc., Subsidiary of Teva 

Pharmaceuticals USA, Inc., 425 Privet Rd., 

Horsham, PA 19044. 

ANDA 062087 ........ Erythromycin Estolate Capsules USP, EQ 250 mg base ......................... Do. 

ANDA 062318 ........ Gentamicin Injection USP, EQ 10 mg base/milliliter (mL) and EQ 40 mg 

base/mL.

Do. 

ANDA 062816 ........ Ampicillin for Injection USP, EQ 125 mg base/vial, EQ 250 mg base/ 

vial, EQ 500 mg base/vial, EQ 1 gram (g) base/vial, and EQ 2 g 

base/vial.

Do. 

ANDA 062994 ........ Ampicillin for Injection USP, EQ 10 g base/vial ........................................ Do. 

ANDA 062999 ........ Erythromycin Delayed-Release Tablets USP, 500 mg ............................. Barr Laboratories, Inc., Subsidiary of Teva 

Pharmaceuticals USA, Inc., 425 Privet Rd., 

Horsham, PA 19044. 

ANDA 064036 ........ Cefuroxime for Injection USP, EQ 7.5 g base/vial ................................... Watson Laboratories, Inc., Subsidiary of Teva 

Pharmaceuticals USA, Inc. 

ANDA 070296 ........ Diazepam Injection USP, 5 mg/mL ........................................................... Do. 

ANDA 070412 ........ Furosemide Tablets USP, 20 mg .............................................................. Do. 

ANDA 070435 ........ Ibuprofen Tablets USP, 200 mg ............................................................... Do. 

ANDA 070436 ........ Ibuprofen Tablets USP, 400 mg ............................................................... Do. 

ANDA 070437 ........ Ibuprofen Tablets USP, 600 mg ............................................................... Do. 

ANDA 070449 ........ Furosemide Tablets USP, 20 mg .............................................................. Do. 

ANDA 070450 ........ Furosemide Tablets USP, 40 mg .............................................................. Do. 

ANDA 070515 ........ Tolazamide Tablets USP, 500 mg ............................................................ Do. 

ANDA 070528 ........ Furosemide Tablets USP, 80 mg .............................................................. Do. 

ANDA 071238 ........ Doxepin Hydrochloride (HCl) Capsules USP, EQ 50 mg base ................ Do. 

ANDA 071547 ........ Ibuprofen Tablets USP, 800 mg ............................................................... Do. 

ANDA 072397 ........ Diazepam Injection USP, 5 mg/mL ........................................................... Do. 

ANDA 072407 ........ Fenoprofen Calcium Tablets USP, EQ 600 mg base ............................... Do. 

ANDA 072602 ........ Fenoprofen Calcium Tablets USP, EQ 600 mg base ............................... Do. 

ANDA 072630 ........ Albuterol Tablets USP, EQ 4 mg base ..................................................... Do. 

ANDA 072825 ........ Baclofen Tablets USP, 20 mg ................................................................... Do. 

ANDA 073013 ........ Metaproterenol Sulfate Tablets USP, 10 mg ............................................ Do. 

ANDA 073445 ........ Meperidine HCl Injection USP, 100 mg/mL .............................................. Do. 

ANDA 074025 ........ Guanabenz Acetate Tablets USP, EQ 4 mg base and EQ 8 mg base ... Do. 

ANDA 074114 ........ Dobutamine Injection USP, EQ 12.5 mg base/mL ................................... Do. 

ANDA 074163 ........ Naproxen Tablets USP, 250 mg, 375 mg, and 500 mg ........................... Do. 

ANDA 074287 ........ Piroxicam Capsules USP, 10 mg and 20 mg ........................................... Do. 

ANDA 074303 ........ Pentamidine Isethionate for Injection, 300 mg/vial ................................... Do. 

ANDA 074437 ........ Pindolol Tablets USP, 5 mg and 10 mg ................................................... Do. 

ANDA 074456 ........ Alprazolam Tablets USP, 0.25 mg, 0.5 mg, and 1 mg ............................. Do. 

ANDA 077643 ........ Topiramate Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg .............. Do. 

ANDA 080728 ........ Diphenhydramine HCl Capsules USP, 25 mg .......................................... Do. 

ANDA 080968 ........ Dexamethasone Tablets USP, 0.75 mg ................................................... Do. 

ANDA 081040 ........ Chlorzoxazone Tablets USP, 500 mg ....................................................... Do. 

ANDA 081149 ........ Hydroxyzine HCl Tablets USP, 10 mg ...................................................... Do. 

ANDA 081189 ........ Hydrochlorothiazide Tablets USP, 25 mg ................................................. Do. 

ANDA 081216 ........ Estropipate Tablets USP, 6 mg ................................................................ Do. 

ANDA 083232 ........ Hydrochlorothiazide Tablets USP, 50 mg ................................................. Do. 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 204 / Tuesday, October 24, 2017 / Notices 49215 

TABLE 1—Continued 

Application No. Drug Applicant 

ANDA 085720 ........ Meprobamate Tablets USP, 200 mg ........................................................ Do. 

ANDA 085721 ........ Meprobamate Tablets USP, 400 mg ........................................................ Do. 

ANDA 085778 ........ Hydroxyzine HCl Injection USP, 25 mg/mL .............................................. Do. 

ANDA 086096 ........ Chlorpheniramine Maleate Injection USP, 10 mg/mL ............................... Do. 

ANDA 086189 ........ Ergoloid Mesylates Sublingual Tablets USP, 0.5 mg ............................... Do. 

ANDA 086598 ........ Nandrolone Decanoate Injection USP, 100 mg/mL .................................. Do. 

ANDA 086795 ........ Chlorothiazide Tablets USP, 250 mg ........................................................ Do. 

ANDA 087183 ........ Ergoloid Mesylates Sublingual Tablets USP, 1 mg .................................. Do. 

ANDA 087296 ........ Chlorthalidone Tablets USP, 25 mg ......................................................... Do. 

ANDA 087521 ........ Chlorthalidone Tablets USP, 50 mg ......................................................... Do. 

ANDA 087772 ........ Prednisone Tablets USP, 50 mg .............................................................. Do. 

ANDA 087979 ........ Chloroquine Phosphate Tablets USP, EQ 150 mg base ......................... Do. 

ANDA 088030 ........ Chloroquine Phosphate Tablets USP, EQ 300 mg base ......................... Do. 

ANDA 089042 ........ Procainamide HCl Extended-Release Tablets USP, 750 mg ................... Do. 

Therefore, approval of the 

applications listed in table 1, and all 

amendments and supplements thereto, 

is hereby withdrawn as of November 24, 

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 table 1 

that are in inventory on the date that 

this notice becomes effective (see the 

DATES section) 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: October 18, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–23046 Filed 10–23–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Allergy and 

Infectious Diseases; Notice of Closed 

Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Allergy and Infectious Diseases Special 

Emphasis Panel; NIAID SBIR Phase II 

Clinical Trial Implementation Cooperative 

Agreement (U44). 

Date: November 17, 2017. 

Time: 1:00 p.m. to 4:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5601 

Fishers Lane, Rockville, MD 20892 

(Telephone Conference Call). 

Contact Person: Vasundhara Varthakavi, 

Ph.D., DVM, Scientific Review Officer, 

Scientific Review Program, Division of 

Extramural Activities, Room 3E70, National 

Institutes of Health, NIAID, 5601 Fishers 

Lane, MSC 9823, Bethesda, MD 20892–9823, 

(240) 669–5020, varthakaviv@niaid.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.855, Allergy, Immunology, 

and Transplantation Research; 93.856, 

Microbiology and Infectious Diseases 

Research, National Institutes of Health, HHS) 

Dated: October 18, 2017. 

Natasha M. Copeland, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–22967 Filed 10–23–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Center for Scientific Review; Notice of 

Closed Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meetings. 

The meetings will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; 

International Research Ethics Training. 

Date: November 16, 2017. 

Time: 8:00 a.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892. 

Contact Person: Karin F. Helmers, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 3148, 

MSC 7770, Bethesda, MD 20892, (301) 254– 

9975, helmersk@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; PAR16–121 

Early-Stage Preclinical Validation of 

Therapeutic Leads for Diseases of Interest to 

the NIDDK (R01). 

Date: November 16, 2017. 

Time: 12:00 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Virtual Meeting). 

Contact Person: Raul Rojas, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6185, 

Bethesda, MD 20892, (301) 451–6319, rojasr@

mail.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel; Member 

Conflict: Macromolecular Structure and 

Function. 

Date: November 20, 2017. 

Time: 1:00 p.m. to 6:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: C-L Albert Wang, Ph.D., 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 


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