Hospira, Inc., et al.; Withdrawal of Approval of One New Drug Application and Two Abbreviated New Drug Applications, 33440-33441 [E8-13273]
Download as PDF
<![CDATA[
33440
Federal Register / Vol. 73, No. 114 / Thursday, June 12, 2008 / Notices
annual report. Based on our knowledge
of the need to update information on
susceptibility test interpretive criteria,
susceptibility test methods, and quality
control parameters in the labeling for
systemic antibacterial drug products for
human use, we estimate that, annually,
only 2 applicants will submit the
written justification described
previously and in the draft guidance.
We also estimate that each justification
will take approximately 16 hours to
prepare and submit to FDA as general
correspondence and as part of the
annual report.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
Justification submitted as general
correspondence and in the annual report
1 There
No. of Responses per
Respondent
2
Hours Per
Response
Total Responses
1
2
Total Hours
16
Food and Drug Administration
applications have agreed in writing to
permit FDA to withdraw approval of the
applications and have waived their
opportunity for a hearing.
[Docket No. FDA–2008–0321]
IV. Electronic Access
DATES:
Hospira, Inc., et al.; Withdrawal of
Approval of One New Drug Application
and Two Abbreviated New Drug
Applications
FOR FURTHER INFORMATION CONTACT:
Florine P. Purdie, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366,
Silver Spring, MD 20993–0002, 301–
796–3601.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/cder/guidance/
index.htm or https://
www.regulations.gov.
Dated: June 9, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. 08–1350 Filed 6–10–08; 11:31 am]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
BILLING CODE 4160–01–S
Notice.
Application No.
Effective June 12, 2008.
FDA
informed the holders of the following
applications that the agency believes a
potential problem associated with
edetate disodium is sufficiently serious
that the following drug products should
be removed from the market:
SUPPLEMENTARY INFORMATION:
The Food and Drug
Administration (FDA) is withdrawing
approval of one new drug application
(NDA) and two abbreviated new drug
applications (ANDAs) for edetate
disodium injection. The holders of these
SUMMARY:
Drug
Applicant
NDA 11–355
ENDRATE (edetate disodium) Injection
Hospira, Inc., 275 North Field Dr.,
Lake Forest, IL 60045– 5046
ANDA 40–376
Edetate Disodium Injection
Apotex Inc., 150 Signet Dr., Toronto,
Ontario, Canada M9L 1T9
ANDA 40–437
mstockstill on PROD1PC66 with NOTICES
32
are no capital costs or operating and maintenance costs associated with this collection of information.
Edetate Disodium Injection
Bioniche Pharma, 272 E. Deerpath Rd.,
suite 304, Lake Forest, IL 60045
Edetate disodium is indicated for the
treatment of hypercalcemia and for the
control of ventricular arrhythmias
associated with digitalis toxicity.
Hospira, Inc. (Hospira), Apotex Inc.
(Apotex), and Bioniche Pharma
(Bioniche) have agreed in writing to
permit FDA to withdraw approval of
their respective applications (listed in
the table of this document), and to
voluntarily remove their respective
products from the market, under
§ 314.150(d) (21 CFR 314.150(d)).
On January 16, 2008, FDA issued a
public health advisory to alert patients
and healthcare professionals about
important safety information concerning
the drug edetate disodium (see ‘‘FDA
VerDate Aug<31>2005
21:47 Jun 11, 2008
Jkt 214001
Public Health Advisory: Edetate
Disodium (Marketed as ENDRATE and
Generic Products),’’ available on the
Internet at https://www.fda.gov/cder/
drug/infopage/edetateldisodium/
default.htm). As noted in the January
16, 2008, Public Health Advisory, there
have been cases where children and
adults have died when they were
mistakenly given edetate disodium
instead of edetate calcium disodium
(calcium disodium versenate) or when
edetate disodium was used for
indications other than those approved
by FDA. FDA asked Hospira, Apotex,
and Bioniche to voluntarily remove
their products (listed in the table of this
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
document) from the market because of
safety concerns.
Hospira’s NDA 11–355 for ENDRATE
was initially approved in 1959 solely on
the basis of safety. The 1962
amendments to the Federal Food, Drug,
and Cosmetic Act (the act) required that
drugs be shown to be effective as well.
To accomplish this, FDA initiated the
Drug Efficacy Study Implementation
(DESI) review to evaluate the
effectiveness of drugs that had been
previously approved on safety grounds
alone. In its DESI review of edetate
disodium, FDA concluded that edetate
disodium was effective for the treatment
of hypercalcemia and for the control of
ventricular arrhythmias associated with
E:\FR\FM\12JNN1.SGM
12JNN1
mstockstill on PROD1PC66 with NOTICES
Federal Register / Vol. 73, No. 114 / Thursday, June 12, 2008 / Notices
digitalis toxicity, the two approved
indications for the drug (35 FR 437,
January 13, 1970).
In a letter dated September 17, 2007,
FDA informed Hospira that the agency
was reevaluating the safety and efficacy
of ENDRATE (edetate disodium)
Injection based on reports of fatal
medication errors and reports of serious
adverse reactions associated with this
product. In its September 17, 2007,
letter, FDA asked Hospira for additional
information related to the safety of
ENDRATE (edetate disodium) Injection.
On September 19, 2007, FDA sent
letters to Apotex and Bioniche for
ANDAs 40–376 and 40–437,
respectively, requesting the same
information for generic versions of
edetate disodium. In a letter dated
October 1, 2007, Hospira provided the
postmarketing safety information FDA
requested on ENDRATE (edetate
disodium). In its October 1, 2007, letter,
Hospira stated that ‘‘[b]ased on the
limited indications for ENDRATE
(edetate disodium) and the availability
of alternate medical products that offer
a superior risk-benefit profile,’’ Hospira
determined that ‘‘the product is not
medically necessary.’’
In a letter dated December 7, 2007,
under § 314.150(d), FDA asked Hospira
to waive its opportunity for a hearing
(otherwise provided for under part 314
(21 CFR part 314)) to permit FDA to
withdraw approval of NDA 11–355, and
to voluntarily remove ENDRATE
(edetate disodium) from the market. In
a letter dated December 20, 2007,
Hospira concurred with FDA’s
determination to withdraw approval of
NDA 11–355, ENDRATE (edetate
disodium), under § 314.150(d); waived
its opportunity for a hearing; and agreed
to voluntarily remove ENDRATE from
the market. Hospira initiated a recall of
the product.
In separate telephone conversations
on April 8, 2008, FDA asked Apotex and
Bioniche, under § 314.150(d), to permit
FDA to withdraw approval of ANDAs
40–376 and 40–437, respectively, for
generic versions of edetate disodium,
and to waive their opportunity for a
hearing. Apotex and Bioniche, in letters
dated April 9, 2008, and April 17, 2008,
respectively, agreed to withdraw their
ANDAs under § 314.150(d). Both
Apotex and Bioniche indicated that
alternative drug products that offer a
superior risk-benefit profile are
currently available for the approved
indications for edetate disodium
injection. Both Apotex and Bioniche
waived their opportunity for a hearing
(otherwise provided under part 314). In
its April 9, 2008, letter, Apotex stated it
has never marketed ANDA 40–376. In
VerDate Aug<31>2005
21:47 Jun 11, 2008
Jkt 214001
its April 17, 2008, letter, Bioniche
agreed to voluntarily remove its edetate
disodium product from the market.
Therefore, under section 505(e) of the
act (21 U.S.C. 355(e)), § 314.150(d), and
under authority delegated to the
Director, Center for Drug Evaluation and
Research, by the Commissioner of Food
and Drugs, approval of the applications
listed in the table of this document, and
all amendments and supplements
thereto, is withdrawn (see DATES).
Distribution of these products in
interstate commerce without an
approved application is illegal and
subject to regulatory action (see sections
505(a) and 301(d) of the act (21 U.S.C.
355(a) and 331(d)). On the basis of the
circumstances described in this
document that led to the withdrawal of
approval of the applications listed in the
table of this document, the agency will
remove these products from the list of
drug products with effective approvals
published in FDA’s ‘‘Approved Drug
Products With Therapeutic Equivalence
Evaluations,’’ referred to as the ‘‘Orange
Book.’’
Dated: May 15, 2008.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation
and Research.
[FR Doc. E8–13273 Filed 6–11–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(cX4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Musculoskeletal Tissue
Engineering.
Date: June 16, 2008.
Time: 10 a.m. to 12:30 p.m.
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
33441
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: John P. Holden, PhD,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 4211, MSC 7814, Bethesda, MD 20892,
301–496–8551, holdenjo@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Orthopaedic
Device-associated Immunology.
Date: June 20, 2008.
Time: 8 a.m. to 9:30 a.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: John P. Holden, PhD,
Center for Scientific Review, National
Institutes of Health, 6701 Rockledge Drive,
Room 4211, MSC 7814, Bethesda, MD 20892,
301–496–8551, holdenjo@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: CNS Disorders and Clinical
Neuroscience.
Date: July 8, 2008.
Time: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Alexander Yakovlev, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5206,
MSC 7846, Bethesda, MD 20892,
301–435–1254, yakovleva@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Minority
Fellowships in Neurobiology and
Development.
Date: July 14, 2008.
Time: 8 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Fairmont Washington, DC, 2401
M Street, NW., Washington, DC 20037.
Contact Person: Cathy J. Wedeen, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3213,
MSC 7808, Bethesda, MD 20892,
301–435–1191, wedeenc@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
E:\FR\FM\12JNN1.SGM
12JNN1
]]>Agencies
[Federal Register Volume 73, Number 114 (Thursday, June 12, 2008)]
[Notices]
[Pages 33440-33441]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13273]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-0321]
Hospira, Inc., et al.; Withdrawal of Approval of One New Drug
Application and Two Abbreviated New Drug Applications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is withdrawing approval
of one new drug application (NDA) and two abbreviated new drug
applications (ANDAs) for edetate disodium injection. The holders of
these applications have agreed in writing to permit FDA to withdraw
approval of the applications and have waived their opportunity for a
hearing.
DATES: Effective June 12, 2008.
FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993-0002, 301-
796-3601.
SUPPLEMENTARY INFORMATION: FDA informed the holders of the following
applications that the agency believes a potential problem associated
with edetate disodium is sufficiently serious that the following drug
products should be removed from the market:
------------------------------------------------------------------------
Application No. Drug Applicant
------------------------------------------------------------------------
NDA 11-355 ENDRATE (edetate Hospira, Inc., 275 North
disodium) Injection Field Dr.,
Lake Forest, IL 60045-
5046
------------------------------------------------------------------------
ANDA 40-376 Edetate Disodium Apotex Inc., 150 Signet
Injection Dr., Toronto,
Ontario, Canada M9L 1T9
------------------------------------------------------------------------
ANDA 40-437 Edetate Disodium Bioniche Pharma, 272 E.
Injection Deerpath Rd.,
suite 304, Lake Forest,
IL 60045
------------------------------------------------------------------------
Edetate disodium is indicated for the treatment of hypercalcemia
and for the control of ventricular arrhythmias associated with
digitalis toxicity. Hospira, Inc. (Hospira), Apotex Inc. (Apotex), and
Bioniche Pharma (Bioniche) have agreed in writing to permit FDA to
withdraw approval of their respective applications (listed in the table
of this document), and to voluntarily remove their respective products
from the market, under Sec. 314.150(d) (21 CFR 314.150(d)).
On January 16, 2008, FDA issued a public health advisory to alert
patients and healthcare professionals about important safety
information concerning the drug edetate disodium (see ``FDA Public
Health Advisory: Edetate Disodium (Marketed as ENDRATE and Generic
Products),'' available on the Internet at https://www.fda.gov/cder/drug/
infopage/edetate_disodium/default.htm). As noted in the January 16,
2008, Public Health Advisory, there have been cases where children and
adults have died when they were mistakenly given edetate disodium
instead of edetate calcium disodium (calcium disodium versenate) or
when edetate disodium was used for indications other than those
approved by FDA. FDA asked Hospira, Apotex, and Bioniche to voluntarily
remove their products (listed in the table of this document) from the
market because of safety concerns.
Hospira's NDA 11-355 for ENDRATE was initially approved in 1959
solely on the basis of safety. The 1962 amendments to the Federal Food,
Drug, and Cosmetic Act (the act) required that drugs be shown to be
effective as well. To accomplish this, FDA initiated the Drug Efficacy
Study Implementation (DESI) review to evaluate the effectiveness of
drugs that had been previously approved on safety grounds alone. In its
DESI review of edetate disodium, FDA concluded that edetate disodium
was effective for the treatment of hypercalcemia and for the control of
ventricular arrhythmias associated with
[[Page 33441]]
digitalis toxicity, the two approved indications for the drug (35 FR
437, January 13, 1970).
In a letter dated September 17, 2007, FDA informed Hospira that the
agency was reevaluating the safety and efficacy of ENDRATE (edetate
disodium) Injection based on reports of fatal medication errors and
reports of serious adverse reactions associated with this product. In
its September 17, 2007, letter, FDA asked Hospira for additional
information related to the safety of ENDRATE (edetate disodium)
Injection.
On September 19, 2007, FDA sent letters to Apotex and Bioniche for
ANDAs 40-376 and 40-437, respectively, requesting the same information
for generic versions of edetate disodium. In a letter dated October 1,
2007, Hospira provided the postmarketing safety information FDA
requested on ENDRATE (edetate disodium). In its October 1, 2007,
letter, Hospira stated that ``[b]ased on the limited indications for
ENDRATE (edetate disodium) and the availability of alternate medical
products that offer a superior risk-benefit profile,'' Hospira
determined that ``the product is not medically necessary.''
In a letter dated December 7, 2007, under Sec. 314.150(d), FDA
asked Hospira to waive its opportunity for a hearing (otherwise
provided for under part 314 (21 CFR part 314)) to permit FDA to
withdraw approval of NDA 11-355, and to voluntarily remove ENDRATE
(edetate disodium) from the market. In a letter dated December 20,
2007, Hospira concurred with FDA's determination to withdraw approval
of NDA 11-355, ENDRATE (edetate disodium), under Sec. 314.150(d);
waived its opportunity for a hearing; and agreed to voluntarily remove
ENDRATE from the market. Hospira initiated a recall of the product.
In separate telephone conversations on April 8, 2008, FDA asked
Apotex and Bioniche, under Sec. 314.150(d), to permit FDA to withdraw
approval of ANDAs 40-376 and 40-437, respectively, for generic versions
of edetate disodium, and to waive their opportunity for a hearing.
Apotex and Bioniche, in letters dated April 9, 2008, and April 17,
2008, respectively, agreed to withdraw their ANDAs under Sec.
314.150(d). Both Apotex and Bioniche indicated that alternative drug
products that offer a superior risk-benefit profile are currently
available for the approved indications for edetate disodium injection.
Both Apotex and Bioniche waived their opportunity for a hearing
(otherwise provided under part 314). In its April 9, 2008, letter,
Apotex stated it has never marketed ANDA 40-376. In its April 17, 2008,
letter, Bioniche agreed to voluntarily remove its edetate disodium
product from the market.
Therefore, under section 505(e) of the act (21 U.S.C. 355(e)),
Sec. 314.150(d), and under authority delegated to the Director, Center
for Drug Evaluation and Research, by the Commissioner of Food and
Drugs, approval of the applications listed in the table of this
document, and all amendments and supplements thereto, is withdrawn (see
DATES). Distribution of these products in interstate commerce without
an approved application is illegal and subject to regulatory action
(see sections 505(a) and 301(d) of the act (21 U.S.C. 355(a) and
331(d)). On the basis of the circumstances described in this document
that led to the withdrawal of approval of the applications listed in
the table of this document, the agency will remove these products from
the list of drug products with effective approvals published in FDA's
``Approved Drug Products With Therapeutic Equivalence Evaluations,''
referred to as the ``Orange Book.''
Dated: May 15, 2008.
Douglas C. Throckmorton,
Deputy Director, Center for Drug Evaluation and Research.
[FR Doc. E8-13273 Filed 6-11-08; 8:45 am]
BILLING CODE 4160-01-S
