[Federal Register Volume 73, Number 114 (Thursday, June 12, 2008)]
[Notices]
[Pages 33440-33441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-13273]
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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.
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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:
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Application No. Drug Applicant
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NDA 11-355 ENDRATE (edetate Hospira, Inc., 275 North
disodium) Injection Field Dr.,
Lake Forest, IL 60045-
5046
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ANDA 40-376 Edetate Disodium Apotex Inc., 150 Signet
Injection Dr., Toronto,
Ontario, Canada M9L 1T9
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ANDA 40-437 Edetate Disodium Bioniche Pharma, 272 E.
Injection Deerpath Rd.,
suite 304, Lake Forest,
IL 60045
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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 http://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