39102 Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices 

Jeffrey M. Zirger, 

Acting Chief, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–16947 Filed 8–7–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2485] 

Fougera Pharmaceuticals, Inc., et al.; 

Withdrawal of Approval of 27 

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 27 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withdrawn. 

DATES: Approval is withdrawn as of 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 7, 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 061467 ......... Pyocidin-Otic (hydrocortisone and polymyxin B sulfate) Otic Solution, 5 milligrams (mg)/10,000 units per milliliter (mL).Fougera Pharmaceuticals, Inc., 60 

Baylis Rd., P.O. Box 2006, Melville, 

NY 11747. 

ANDA 061653 ......... Tetrex (tetracycline phosphate complex) Capsules, Equivalent to (EQ) 100 mg 

Hydrochloride (HCl), EQ 250 mg HCl and EQ 500 mg HCl.

Bristol-Myers Squibb Co., P.O. Box 

4000, Princeton, NJ 08543. 

ANDA 061658 ......... Bristacycline (tetracycline HCl) Capsules, 250 mg and 500 mg ........................... Do. 

ANDA 061711 ......... Penicillin V Potassium Tablets .............................................................................. Do. 

ANDA 061721 ......... Ampicillin Capsules, 250 mg and 500 mg ............................................................. Do. 

ANDA 061726 ......... Azotrex (phenazopyridine HCl, sulfamethizole and tetracycline phosphate complex) Capsules, 50 mg/250 mg/125 mg.Do. 

ANDA 061790 ......... Hetacillin Potassium ............................................................................................... Do. 

ANDA 061887 ......... Bristamycin (erythromycin stearate) Tablets, EQ 250 mg base ........................... Do. 

ANDA 061888 ......... Bristacycline (tetracycline HCl) Capsules, 250 mg and 500 mg ........................... Do. 

ANDA 061889 ......... Tetrex (tetracycline phosphate complex) Capsules, EQ 250 mg HCl and EQ 

500 mg HCl.

Do. 

ANDA 061890 ......... Azotrex (phenazopyridine HCl, sulfamethizole, and tetracycline) Capsules, 50 

mg/250 mg/125 mg.

Do. 

ANDA 061891 ......... Tetrex-S (tetracycline) Syrup, 125 mg/5 mL ......................................................... Do. 

ANDA 061975 ......... Cephradine Powder for Injection ........................................................................... Do. 

ANDA 062168 ......... Cephradine Tablets ................................................................................................ Do. 

ANDA 062259 ......... Amphotericin B for Use in Parenteral Products .................................................... Do. 

ANDA 062543 ......... Mycolog (nystatin, neomycin sulfate, gramicidin, and triamcinolone acetonide) 

Ointment.

Do. 

ANDA 071793 ......... Foamcoat (aluminum hydroxide; magnesium trisilicate) Chewable Tablets, 80 

mg/20 mg (OTC).

Guardian Drug Co., 2 Charles Court, 

Dayton, NJ 08810. 

ANDA 072035 ......... Nuprin (ibuprofen) Tablets, 200 mg ....................................................................... Bristol-Myers Squibb Co. 

ANDA 072036 ......... Nuprin (ibuprofen) Tablets, 200 mg ....................................................................... Do. 

ANDA 074911 ......... Phrenilin with Caffeine and Codeine (acetaminophen, butalbital, caffeine, and 

codeine phosphate) Capsules, 325 mg/50 mg/40 mg/30 mg.

Valeant Pharmaceuticals North America, LLC, 400 Somerset Corporate 

Blvd., Bridgewater, NJ 08807. 

ANDA 074944 ......... Atracurium Besylate Injection, 10 mg/mL .............................................................. Watson Laboratories, Inc., Subsidiary 

of Teva Pharmaceuticals USA, Inc., 

425 Privet Rd., Horsham, PA 19044. 

ANDA 075206 ......... Cytosar-U (cytarabine) for Injection USP, 100 mg/vial, 500 mg/vial, 1 gram (g)/ 

vial, and 2 g/vial.

Teva Pharmaceuticals USA, Inc., 425 

Privet Rd., Horsham, PA 19044. 

ANDA 077337 ......... Rosiglitazone Maleate and Metformin HCl Tablets, EQ 1 mg base/500 mg, EQ 

2 mg base/500 mg, EQ 4 mg base/500 mg, EQ 2 mg base/1 g, and EQ 4 mg 

base/1 g.

Do. 

ANDA 077930 ......... Meloxicam Tablets, 7.5 mg and 15 mg ................................................................. Impax Laboratories, Inc., 30831 

Huntwood Ave., Hayward, CA 94544. 

ANDA 080658 ......... Procaine HCl Injection, 1% and 2% ...................................................................... Watson Laboratories, Inc., Subsidiary 

of Teva Pharmaceuticals USA, Inc. 

ANDA 083128 ......... Hydrocortisone Acetate Injectable Suspension, 25 mg/mL ................................... Do. 

ANDA 090181 ......... Ifosfamide for Injection, 1 g/20 mL and 3 g/60 mL ............................................... Fresenius Kabi USA, LLC, Three Corporate Dr., Lake Zurich, IL 60047. 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices 39103 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of September 7, 

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 7, 

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 3, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16985 Filed 8–7–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2702] 

Merck Sharp & Dohme Corporation, et 

al.; Withdrawal of Approval of Four 

New Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

withdrawing approval of four 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 

September 7, 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 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 

NDA 005619 ............ Aminohippurate Sodium (PAH) 20% sterile solution Injection, 2 grams in 10 milliliter (mL) vials.Merck Sharp & Dohme Corp., Subsidiary of Merck & Company, Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889. 

NDA 008506 ............ Hydrocortone (hydrocortisone) Tablets USP, 10 milligrams 

(mg) and 20 mg.

Do. 

NDA 011891 ............ Durabolin (nandrolone phenpropionate) Injection, 25 mg/mL 

and 50 mg/mL.

Organon USA, Inc., Subsidiary of Merck & Company, Inc., 

2000 Galloping Hill Rd., Kenilworth, NJ 07033. 

NDA 020301 ............ Ortho-Cept (desogestrel and ethinyl estradiol) Tablets USP, 

0.15 mg/0.03 mg (21-Day and 28-Day Regimens).

Janssen Pharmaceuticals, Inc., 920 U.S. Hwy. 202, P.O. 

Box 300, Raritan, NJ 08869–0602. 

Therefore, approval of the 

applications listed in the table, and all 

amendments and supplements thereto, 

is hereby withdrawn as of September 7, 

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 7, 

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 3, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–16982 Filed 8–7–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2016–D–1692] 

Elemental Impurities in Drug Products; 

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 

‘‘Elemental Impurities in Drug 

Products.’’ This guidance finalizes the 

draft guidance issued July 1, 2016, 

which provides recommendations 

regarding the control of elemental 

impurities of human drug products 

marketed in the United States consistent 

with the implementation of 

International Council for Harmonisation 

(ICH) guidance for industry entitled 

‘‘Q3D Elemental Impurities’’ (ICH Q3D). 

This guidance will also assist 

manufacturers of compendial drug 

products in responding to the issuance 

of the United States Pharmacopeia 

(USP) requirement for the control of 

elemental impurities. 

DATES: The announcement of the 

guidance is published in the Federal 

Register on August 8, 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 


sradovich on DSK3GMQ082PROD with NOTICES