[Federal Register Volume 83, Number 153 (Wednesday, August 8, 2018)]
[Notices]
[Page 39103]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16982]


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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.

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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that the approval of the applications be withdrawn.

DATES: Approval is withdrawn as of September 7, 2018.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 Sec.  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 Sec.  314.150(c) is without prejudice to 
refiling.

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       Application No.                Drug                Applicant
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NDA 005619..................  Aminohippurate        Merck Sharp & Dohme
                               Sodium (PAH) 20%      Corp., Subsidiary
                               sterile solution      of Merck & Company,
                               Injection, 2 grams    Inc., 1 Merck Dr.,
                               in 10 milliliter      P.O. Box 100,
                               (mL) vials.           Whitehouse Station,
                                                     NJ 08889.
NDA 008506..................  Hydrocortone          Do.
                               (hydrocortisone)
                               Tablets USP, 10
                               milligrams (mg) and
                               20 mg.
NDA 011891..................  Durabolin             Organon USA, Inc.,
                               (nandrolone           Subsidiary of Merck
                               phenpropionate)       & Company, Inc.,
                               Injection, 25 mg/mL   2000 Galloping Hill
                               and 50 mg/mL.         Rd., Kenilworth, NJ
                                                     07033.
NDA 020301..................  Ortho-Cept            Janssen
                               (desogestrel and      Pharmaceuticals,
                               ethinyl estradiol)    Inc., 920 U.S. Hwy.
                               Tablets USP, 0.15     202, P.O. Box 300,
                               mg/0.03 mg (21-Day    Raritan, NJ 08869-
                               and 28-Day            0602.
                               Regimens).
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    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


