Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19 New Drug Applications, 915-916 [2020-00075]
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Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices
Notice.
Food and Drug Administration
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 19 new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
[Docket No. FDA–2019–N–5843]
DATES:
[FR Doc. 2020–00063 Filed 1–7–20; 8:45 am]
BILLING CODE 4164–01–C
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
AGENCY:
FOR FURTHER INFORMATION CONTACT:
Food and Drug Administration,
HHS.
SUMMARY:
Approval is withdrawn as of
February 7, 2020.
Pharmacia and Upjohn Co., et al.;
Withdrawal of Approval of 19 New
Drug Applications
jbell on DSKJLSW7X2PROD with NOTICES
ACTION:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137.
The
applicants 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 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 004570 ........................
NDA 009838 ........................
Heparin Sodium Injection, 1,000 units/milliliter (mL),
5,000 units/mL, and 10,000 units/mL.
Reserpine Tablets, 0.1 milligram (mg) and 0.25 mg ......
NDA 017063 ........................
Ismotic (isosorbide solution), 100 grams (g)/220 mL .....
NDA 017521 ........................
Dextrose Injection, 0.2 g/mL, 0.3 g/mL, 0.4 g/mL, 0.5 g/
mL, 0.6 g/mL, and 0.7 g/mL.
Imodium (loperamide hydrochloride (HCl)) Capsules, 2
mg.
Pharmacia and Upjohn Co. (a subsidiary of Pfizer Inc.),
235 East 42nd St., New York, NY 10017–7555.
Sandoz Inc., 2555 W. Midway Blvd., Broomfield, CO
80020–1632.
Alcon Research, LLC, 6201 South Freeway, Fort
Worth, TX 76134–2099.
Baxter Healthcare Corp., 1 Baxter Parkway, Deerfield,
IL 60015.
Johnson and Johnson Consumer Inc., McNeil Consumer Healthcare Division, 7050 Camp Hill Rd., Fort
Washington, PA 19034.
Do.
NDA 017690 ........................
NDA 017694 ........................
VerDate Sep<11>2014
17:18 Jan 07, 2020
Imodium (loperaminde HCl) Capsules, 2 mg .................
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Dated: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
915
916
Federal Register / Vol. 85, No. 5 / Wednesday, January 8, 2020 / Notices
Application No.
Drug
Applicant
NDA 018361 ........................
Serophene (clomiphene citrate) Tablets, 50 mg ............
NDA 020262 ........................
Taxol (paclitaxel) Injection, 6 mg/mL ..............................
NDA 020264 ........................
Megace (megestrol acetate) Oral Suspension, 40 mg/
mL.
Zerit (stavudine) for Oral Solution, 1 mg/mL ..................
Exelon (rivastigmine tartrate) Capsules, equivalent to
(EQ) 1.5 mg base, EQ 3 mg base, EQ 4.5 mg base,
and EQ 6 mg base.
Exelon (rivastigmine tartrate) Solution, EQ 2 mg base/
mL.
Exalgo (hydromorphone HCl) Extended-Release Tablets, 8 mg, 12 mg, 16 mg, and 32 mg.
Bupivacaine HCl and epinephrine bitartrate Injection,
0.5%/0.0091 mg/mL.
Azactam (aztreonam) 10 mg/mL, 20 mg/mL, and 40
mg/mL.
Esomeprazole Strontium Delayed-Release Capsules,
EQ 20 mg base and EQ 40 mg base.
Technivie (ombitasvir, paritaprevir, and ritonavir) Tablets, 12.5 mg/75 mg/50 mg.
Arymo ER (morphine sulfate) Extended-Release Tablets, 15 mg, 30 mg, and 60 mg.
Viekira XR (dasabuvir, ombitasvir, paritaprevir, and
ritonavir) Extended-Release Tablets, 200 mg/8.33
mg/50 mg/33.33 mg.
EMD Serono, Inc., 1 Technology Pl., Rockland, MA
02370.
HQ Specialty Pharma Corp., 120 Route 17 North,
Paramus, NJ 07652.
Bristol-Myers Squibb Co., P.O. Box 4000, Mail Stop:
D.2341, Princeton, NJ 08543–4000.
Do.
Novartis Pharmaceuticals Corp.
NDA 020413 ........................
NDA 020823 ........................
NDA 021025 ........................
NDA 021217 ........................
NDA 022046 ........................
NDA 050632 ........................
NDA 202342 ........................
NDA 207931 ........................
NDA 208603 ........................
NDA 208624 ........................
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of February 7,
2020. Approval of each entire
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
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 February 7,
2020 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: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00075 Filed 1–7–20; 8:45 am]
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BILLING CODE 4164–01–P
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SpecGx LLC, 385 Marshall Ave., Webster Groves, MO
63119.
Hospira, Inc., 275 North Field Dr., Bldg. H1, Lake Forest, IL 60045.
Bristol-Myers Squibb Co.
R2 Pharma, LLC, 11550 North Meridian St., Suite 290,
Carmel, IN 46032–5505.
AbbVie Inc., 1 North Waukegan Rd., Dept. PA77/Bldg.
AP30, North Chicago, IL 60064.
Zyla Life Sciences US Inc., 600 Lee Rd., Suite 100,
Wayne, PA 19087.
AbbVie Inc.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–6098]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Focus Groups as
Used by the Food and Drug
Administration (All Food and Drug
Administration-Regulated Products)
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information for the
generic collection for focus groups as
used by FDA (all FDA-regulated
products).
DATES: Submit either electronic or
written comments on the collection of
information by March 9, 2020.
ADDRESSES: You may submit comments
as follows. Please note that late,
SUMMARY:
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untimely filed comments will not be
considered. Electronic comments must
be submitted on or before March 9,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 9, 2020. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
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
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
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]]>Agencies
[Federal Register Volume 85, Number 5 (Wednesday, January 8, 2020)]
[Notices]
[Pages 915-916]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00075]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-5843]
Pharmacia and Upjohn Co., et al.; Withdrawal of Approval of 19
New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is
withdrawing approval of 19 new drug applications (NDAs) from multiple
applicants. The applicants 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 February 7, 2020.
FOR FURTHER INFORMATION CONTACT: Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226, Silver Spring, MD 20993-0002, 301-
796-3137.
SUPPLEMENTARY INFORMATION: The applicants 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 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 004570.................. Heparin Sodium Pharmacia and Upjohn
Injection, 1,000 Co. (a subsidiary
units/milliliter of Pfizer Inc.),
(mL), 5,000 units/ 235 East 42nd St.,
mL, and 10,000 New York, NY 10017-
units/mL. 7555.
NDA 009838.................. Reserpine Tablets, Sandoz Inc., 2555 W.
0.1 milligram (mg) Midway Blvd.,
and 0.25 mg. Broomfield, CO
80020-1632.
NDA 017063.................. Ismotic (isosorbide Alcon Research, LLC,
solution), 100 6201 South Freeway,
grams (g)/220 mL. Fort Worth, TX
76134-2099.
NDA 017521.................. Dextrose Injection, Baxter Healthcare
0.2 g/mL, 0.3 g/mL, Corp., 1 Baxter
0.4 g/mL, 0.5 g/mL, Parkway, Deerfield,
0.6 g/mL, and 0.7 g/ IL 60015.
mL.
NDA 017690.................. Imodium (loperamide Johnson and Johnson
hydrochloride Consumer Inc.,
(HCl)) Capsules, 2 McNeil Consumer
mg. Healthcare
Division, 7050 Camp
Hill Rd., Fort
Washington, PA
19034.
NDA 017694.................. Imodium (loperaminde Do.
HCl) Capsules, 2 mg.
[[Page 916]]
NDA 018361.................. Serophene EMD Serono, Inc., 1
(clomiphene Technology Pl.,
citrate) Tablets, Rockland, MA 02370.
50 mg.
NDA 020262.................. Taxol (paclitaxel) HQ Specialty Pharma
Injection, 6 mg/mL. Corp., 120 Route 17
North, Paramus, NJ
07652.
NDA 020264.................. Megace (megestrol Bristol-Myers Squibb
acetate) Oral Co., P.O. Box 4000,
Suspension, 40 mg/ Mail Stop: D.2341,
mL. Princeton, NJ 08543-
4000.
NDA 020413.................. Zerit (stavudine) Do.
for Oral Solution,
1 mg/mL.
NDA 020823.................. Exelon (rivastigmine Novartis
tartrate) Capsules, Pharmaceuticals
equivalent to (EQ) Corp.
1.5 mg base, EQ 3
mg base, EQ 4.5 mg
base, and EQ 6 mg
base.
NDA 021025.................. Exelon (rivastigmine Do.
tartrate) Solution,
EQ 2 mg base/mL.
NDA 021217.................. Exalgo SpecGx LLC, 385
(hydromorphone HCl) Marshall Ave.,
Extended-Release Webster Groves, MO
Tablets, 8 mg, 12 63119.
mg, 16 mg, and 32
mg.
NDA 022046.................. Bupivacaine HCl and Hospira, Inc., 275
epinephrine North Field Dr.,
bitartrate Bldg. H1, Lake
Injection, 0.5%/ Forest, IL 60045.
0.0091 mg/mL.
NDA 050632.................. Azactam (aztreonam) Bristol-Myers Squibb
10 mg/mL, 20 mg/mL, Co.
and 40 mg/mL.
NDA 202342.................. Esomeprazole R2 Pharma, LLC,
Strontium Delayed- 11550 North
Release Capsules, Meridian St., Suite
EQ 20 mg base and 290, Carmel, IN
EQ 40 mg base. 46032-5505.
NDA 207931.................. Technivie AbbVie Inc., 1 North
(ombitasvir, Waukegan Rd., Dept.
paritaprevir, and PA77/Bldg. AP30,
ritonavir) Tablets, North Chicago, IL
12.5 mg/75 mg/50 mg. 60064.
NDA 208603.................. Arymo ER (morphine Zyla Life Sciences
sulfate) Extended- US Inc., 600 Lee
Release Tablets, 15 Rd., Suite 100,
mg, 30 mg, and 60 Wayne, PA 19087.
mg.
NDA 208624.................. Viekira XR AbbVie Inc.
(dasabuvir,
ombitasvir,
paritaprevir, and
ritonavir) Extended-
Release Tablets,
200 mg/8.33 mg/50
mg/33.33 mg.
------------------------------------------------------------------------
Therefore, approval of the applications listed in the table, and
all amendments and supplements thereto, is hereby withdrawn as of
February 7, 2020. Approval of each entire application is withdrawn,
including any strengths and dosage forms inadvertently missing from the
table. 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 February 7, 2020 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: January 2, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-00075 Filed 1-7-20; 8:45 am]
BILLING CODE 4164-01-P
