Merck Sharp & Dohme Corporation, et al.; Withdrawal of Approval of Four New Drug Applications, 39103 [2018-16982]
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Federal Register / Vol. 83, No. 153 / Wednesday, August 8, 2018 / Notices
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is hereby withdrawn as of September 7,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
[Docket No. FDA–2018–N–2702]
Merck Sharp & Dohme Corporation, et
al.; Withdrawal of Approval of Four
New Drug Applications
Food and Drug Administration,
HHS.
ACTION:
Approval is withdrawn as of
September 7, 2018.
DATES:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration
AGENCY:
39103
Notice.
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withdrawn.
SUMMARY:
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.
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.
SUPPLEMENTARY INFORMATION:
Application No.
Drug
Applicant
NDA 005619 ............
Aminohippurate Sodium (PAH) 20% sterile solution Injection, 2 grams in 10 milliliter (mL) vials.
NDA 008506 ............
Hydrocortone (hydrocortisone) Tablets USP, 10 milligrams
(mg) and 20 mg.
Durabolin (nandrolone phenpropionate) Injection, 25 mg/mL
and 50 mg/mL.
Ortho-Cept (desogestrel and ethinyl estradiol) Tablets USP,
0.15 mg/0.03 mg (21-Day and 28-Day Regimens).
Merck Sharp & Dohme Corp., Subsidiary of Merck & Company, Inc., 1 Merck Dr., P.O. Box 100, Whitehouse Station, NJ 08889.
Do.
NDA 011891 ............
NDA 020301 ............
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.
sradovich on DSK3GMQ082PROD with NOTICES
[FR Doc. 2018–16982 Filed 8–7–18; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
22:37 Aug 07, 2018
Jkt 244001
Organon USA, Inc., Subsidiary of Merck & Company, Inc.,
2000 Galloping Hill Rd., Kenilworth, NJ 07033.
Janssen Pharmaceuticals, Inc., 920 U.S. Hwy. 202, P.O.
Box 300, Raritan, NJ 08869–0602.
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:
Electronic Submissions
Notice of availability.
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
SUMMARY:
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
(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:
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
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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
E:\FR\FM\08AUN1.SGM
08AUN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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 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.
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
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).
------------------------------------------------------------------------
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
