[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that the approval of the applications be withdrawn.
DATES: Approval is withdrawn as of September 7, 2018.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