Document ID: FDA-2015-N-1702-0001
Agency: fda
Document Type: Notice
Title: Baxter Healthcare Corporation et al.; Withdrawal of Approval of One New
Drug Application and Four Abbreviated New Drug Applications
Posted Date: 2015-06-10T04:00Z

[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Pages 32966-32967]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14144]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-1702]

Baxter Healthcare Corporation et al.; Withdrawal of Approval of 
One New Drug Application and Four 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) for Ondansetron (ondansetron 
hydrochloride (HCl)) Injection, USP in PL 2408 Plastic Container, 32 
milligrams (mg) in 50 milliliters (mL), single intravenous (IV) dose, 
and four abbreviated new drug applications (ANDAs) for ondansetron HCl 
and Dextrose in 32 mg single IV doses. The holders of these 
applications have voluntarily requested that FDA withdraw approval of 
their applications and have waived their opportunity for a hearing.

DATES: Effective June 10, 2015.

FOR FURTHER INFORMATION CONTACT: Emily Helms Williams, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-3381.

SUPPLEMENTARY INFORMATION: On June 29, 2012, FDA issued a Drug Safety 
Communication to notify health care professionals that the 32 mg, 
single IV dose of ondansetron HCl, indicated for prevention of nausea 
and vomiting associated with initial and repeat courses of emetogenic 
cancer chemotherapy in adult patients, should be avoided due to the 
risk of a specific type of irregular heart rhythm called QT interval 
prolongation, which can lead to Torsades de Pointes, an abnormal, 
potentially fatal heart rhythm. Subsequently, FDA contacted the holders 
of the following applications and informed them that the Agency 
believes that in light of the safety concern associated with 
ondansetron HCl in the 32 mg, single IV dose, the following drug 
products should be removed from the market:

 
------------------------------------------------------------------------
     Application number               Drug                Applicant
------------------------------------------------------------------------
NDA 021915..................  Ondansetron           Baxter Healthcare
                               Hydrochloride         Corporation
                               Injection, USP        (Baxter), 32650 N.
                               premix in Intravia    Wilson Rd., Round
                               Plastic Container.    Lake, IL 60073.
ANDA 077348.................  Ondansetron           Hospira, Inc.
                               Hydrochloride and     (Hospira), 275
                               Dextrose in Plastic   North Field Dr.,
                               Container.            Department 389,
                                                     Bldg. H2-2, Lake
                                                     Forest, IL 60045.
ANDA 077480.................  Ondansetron           Teva Pharmaceuticals
                               Hydrochloride and     USA (Teva), 400
                               Dextrose in Plastic   Chestnut Ridge Rd.,
                               Container.            Woodcliff Lake, NJ
                                                     07677.
ANDA 078291.................  Ondansetron           Bedford Labs
                               Hydrochloride and     (Bedford), 300
                               Dextrose in Plastic   Northfield Rd.,
                               Container.            Bedford, OH 44146.
ANDA 078308.................  Ondansetron           Claris Lifesciences
                               Hydrochloride and     Ltd. (Claris), 2325
                               Dextrose in Plastic   Camino Vida Roble,
                               Container.            Suite A, Carlsbad,
                                                     CA 92011.
------------------------------------------------------------------------

[[Page 32967]]

    As described in this document, the application holders agreed to 
voluntarily remove their respective 32 mg, single IV dose ondansetron 
products from the market, and requested that FDA withdraw approval of 
their respective applications (listed in the preceding table) under 
Sec.  314.150(d) (21 CFR 314.150(d)). On December 4, 2012, FDA issued 
an updated Drug Safety Communication alerting health care professionals 
that these products would be removed from the market because of their 
potential for serious cardiac risks.
    Baxter's Ondansetron (ondansetron HCl) Injection, USP in PL 2408 
Plastic Container, 32 mg/50 mL, single IV dose, was approved in NDA 
021915 on December 27, 2006. In a letter dated November 27, 2012, 
Baxter requested withdrawal of NDA 021915 under 21 CFR 314.150(d), and 
waived its opportunity for a hearing provided under Sec.  314.150(a). 
In a letter dated September 5, 2012, Baxter notified FDA that the 
product was being discontinued. In a contemporaneous notice, FDA is 
announcing its determination that the product was withdrawn from sale 
for reasons of safety or effectiveness and that FDA will not accept or 
approve ANDAs that refer to this drug product.
    Hospira's ondansetron HCl Injection 32 mg/50 mL, single IV dose was 
approved in ANDA 077348 on February 1, 2007. In a letter dated January 
31, 2013, Hospira requested withdrawal of ANDA 077348 under 21 CFR 
314.150(d), and waived its opportunity for a hearing provided under 
Sec.  314.150(a).
    Teva's ondansetron HCl Injection 32 mg/50 mL, single IV dose was 
approved in ANDA 077480 on November 22, 2006. In a letter dated 
November 20, 2012, Teva requested withdrawal of ANDA 077480 under 21 
CFR 314.150(d), and waived its opportunity for a hearing provided under 
Sec.  314.150(a).
    Bedford's ondansetron HCl Injection 32 mg/50 mL, single IV dose was 
approved in ANDA 078291 on April 13, 2009. In a letter dated April 4, 
2014, Bedford requested withdrawal of ANDA 078291, under 21 CFR 
314.150(d), and waived its opportunity for a hearing provided under 
Sec.  314.150(a).
    Claris's ondansetron HCl Injection 32 mg/50 mL, single IV dose, was 
approved in ANDA 078308 on March 17, 2008. In a letter dated November 
16, 2012, through its U.S. agent, CUSTOpharm, Inc., Claris requested 
withdrawal of ANDA 078308 under 21 CFR 314.150(d), and waived its 
opportunity for a hearing provided under Sec.  314.150(a).
    Therefore, under section 505(e) of the Federal Food, Drug, and 
Cosmetic Act (FD&C Act) (21 U.S.C. 355(e)) and 21 CFR 314.150(d), and 
under authority delegated by the Commissioner to the Director, Center 
for Drug Evaluation and Research, 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 
FD&C Act (21 U.S.C. 355(a) and 331(d)). 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,'' generally referred to as the ``Orange 
Book.''

    Dated: June 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14144 Filed 6-9-15; 8:45 am]
 BILLING CODE 4164-01-P