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is hereby withdrawn as of September 7, 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withdrawn. 

DATES: Approval is withdrawn as of 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 


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