80 FR 32966 - Baxter Healthcare Corporation et al.; Withdrawal of Approval of One New Drug Application and Four Abbreviated New Drug Applications
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 80, Issue 111 (June 10, 2015)
Food and Drug Administration
Federal Register Volume 80, Issue 111 (June 10, 2015)
| Page Range | 32966-32967 | |
| FR Document | 2015-14144 |
[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)] [Notices] [Pages 32966-32967] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-14144] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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
![32966 Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of Total annual
Activity or type of respondent responses per burden per Total hours
respondents responses
respondent response
Focus Group Subjects .................................................... 20 0.33 7 1.5 ...................... 10
Total ......................................................................... 49,310 ........................ ........................ ............................ 8,038
1 There are no capital or operating and maintenance costs or associated with this collection of information.
* Includes a total of 8 experimental or observational studies over a 3-year period for each of the 4,000 panel members who are active at the
time of each study. The first study (Study 1) is included in this clearance request; the remaining studies will be funded under separate task or-
ders but are included in this table to present an overall estimate of the burden for each participating panel member.
** Assumes 1,400 additional panel members will be recruited annually (2,800 total) as part of the panel replenishment effort.
The collection burden was estimated and Tompson, T., 2009, Panel Dextrose in 32 mg single IV doses. The
using data from timed-readings of each Conditioning and Attrition in the AP- holders of these applications have
instrument, including the mail and field Yahoo! News Election Panel Study, voluntarily requested that FDA
Paper presented at the American
screeners, enrollment survey, baseline withdraw approval of their applications
Association for Public Opinion Research
survey, panel maintenance 64th Annual Conference. and have waived their opportunity for a
questionnaires, and Study 1 hearing.
questionnaire. Dated: June 4, 2015.
DATES: Effective June 10, 2015.
References Leslie Kux,
Associate Commissioner for Policy. FOR FURTHER INFORMATION CONTACT:
The following references have been Emily Helms Williams, Center for Drug
[FR Doc. 2015–14125 Filed 6–9–15; 8:45 am]
placed on display in the Division of Evaluation and Research, Food and
BILLING CODE 4164–01–P
Dockets Management (HFA–305), Food Drug Administration, 10903 New
and Drug Administration, 5630 Fishers Hampshire Ave., Bldg. 51, Rm. 6280,
Lane, rm. 1061, Rockville, MD 20852, Silver Spring, MD 20993–0002, 301–
DEPARTMENT OF HEALTH AND
and may be seen by interested persons 796–3381.
HUMAN SERVICES
between 9 a.m. and 4 p.m., Monday
through Friday, and are available SUPPLEMENTARY INFORMATION: On June
Food and Drug Administration
electronically at http:// 29, 2012, FDA issued a Drug Safety
www.regulations.gov. [Docket No. FDA–2015–N–1702] Communication to notify health care
1. Baker, R., Blumberg, S., Brick, M., Couper,
professionals that the 32 mg, single IV
Baxter Healthcare Corporation et al.; dose of ondansetron HCl, indicated for
M., Courtright, M., Dennis, J. M.,
Withdrawal of Approval of One New prevention of nausea and vomiting
Dillman, D., Frankel, M., Garland, P.,
Groves, R., Kennedy, C., Krosnick, J. and Drug Application and Four Abbreviated associated with initial and repeat
Lavrakas, P., 2010, American Association New Drug Applications courses of emetogenic cancer
for Public Opinion Research Report on chemotherapy in adult patients, should
AGENCY: Food and Drug Administration,
Online Panels. Public Opinion Quarterly, be avoided due to the risk of a specific
74 (4), pp. 711–781. HHS.
2. Coen, T., Lorch, J. and Piekarski, L., 2005, ACTION: Notice. type of irregular heart rhythm called QT
The Effects of Survey Frequency on interval prolongation, which can lead to
Panelists’ Responses, Worldwide Panel SUMMARY: The Food and Drug Torsades de Pointes, an abnormal,
Research: Developments and Progress, Administration (FDA) is withdrawing potentially fatal heart rhythm.
Amsterdam, European Society for approval of one new drug application Subsequently, FDA contacted the
Opinion and Marketing Research. (NDA) for Ondansetron (ondansetron holders of the following applications
3. Nancarrow, C. and Catwright, T., 2007, hydrochloride (HCl)) Injection, USP in and informed them that the Agency
Online Access Panels and Tracking PL 2408 Plastic Container, 32 believes that in light of the safety
Research, The Conditioning Issue,
International Journal of Market milligrams (mg) in 50 milliliters (mL), concern associated with ondansetron
Research, 49(5), pp. 435–447. single intravenous (IV) dose, and four HCl in the 32 mg, single IV dose, the
4. Kruse, Y., Callegaro, M., Dennis, J. M., abbreviated new drug applications following drug products should be
DiSogra, C., Subias, S., Lawrence, M., (ANDAs) for ondansetron HCl and removed from the market:
Application number Drug Applicant
NDA 021915 ........................ Ondansetron Hydrochloride Injection, USP premix in Baxter Healthcare Corporation (Baxter), 32650 N. Wil-
Intravia Plastic Container. son Rd., Round Lake, IL 60073.
ANDA 077348 ...................... Ondansetron Hydrochloride and Dextrose in Plastic Hospira, Inc. (Hospira), 275 North Field Dr., Depart-
Container. ment 389, Bldg. H2–2, Lake Forest, IL 60045.
asabaliauskas on DSK5VPTVN1PROD with NOTICES
ANDA 077480 ...................... Ondansetron Hydrochloride and Dextrose in Plastic Teva Pharmaceuticals USA (Teva), 400 Chestnut
Container. Ridge Rd., Woodcliff Lake, NJ 07677.
ANDA 078291 ...................... Ondansetron Hydrochloride and Dextrose in Plastic Bedford Labs (Bedford), 300 Northfield Rd., Bedford,
Container. OH 44146.
ANDA 078308 ...................... Ondansetron Hydrochloride and Dextrose in Plastic Claris Lifesciences Ltd. (Claris), 2325 Camino Vida
Container. Roble, Suite A, Carlsbad, CA 92011.
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![Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices 32967
As described in this document, the Therefore, under section 505(e) of the MSC7846, Bethesda, MD 20892, (301) 435–
application holders agreed to Federal Food, Drug, and Cosmetic Act 1021, rovescaa@mail.nih.gov.
voluntarily remove their respective 32 (FD&C Act) (21 U.S.C. 355(e)) and 21 This notice is being published less than 15
mg, single IV dose ondansetron CFR 314.150(d), and under authority days prior to the meeting due to the timing
products from the market, and requested delegated by the Commissioner to the limitations imposed by the review and
funding cycle.
that FDA withdraw approval of their Director, Center for Drug Evaluation and
respective applications (listed in the Research, approval of the applications (Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
preceding table) under § 314.150(d) (21 listed in the table of this document, and 93.333, Clinical Research, 93.306, 93.333,
CFR 314.150(d)). On December 4, 2012, all amendments and supplements 93.337, 93.393–93.396, 93.837–93.844,
FDA issued an updated Drug Safety thereto, is withdrawn (see DATES). 93.846–93.878, 93.892, 93.893, National
Communication alerting health care Distribution of these products in Institutes of Health, HHS)
professionals that these products would interstate commerce without an Dated: June 5, 2015.
be removed from the market because of approved application is illegal and
Anna Snouffer,
their potential for serious cardiac risks. subject to regulatory action (see sections
Baxter’s Ondansetron (ondansetron Deputy Director, Office of Federal Advisory
505(a) and 301(d) of the FD&C Act (21
HCl) Injection, USP in PL 2408 Plastic Committee Policy.
U.S.C. 355(a) and 331(d)). The Agency
Container, 32 mg/50 mL, single IV dose, [FR Doc. 2015–14185 Filed 6–9–15; 8:45 am]
will remove these products from the list
was approved in NDA 021915 on of drug products with effective BILLING CODE 4140–01–P
December 27, 2006. In a letter dated approvals published in FDA’s
November 27, 2012, Baxter requested ‘‘Approved Drug Products With
withdrawal of NDA 021915 under 21 DEPARTMENT OF HEALTH AND
Therapeutic Equivalence Evaluations,’’
CFR 314.150(d), and waived its HUMAN SERVICES
generally referred to as the ‘‘Orange
opportunity for a hearing provided Book.’’
under § 314.150(a). In a letter dated National Institutes of Health
September 5, 2012, Baxter notified FDA Dated: June 4, 2015.
Leslie Kux, Center for Scientific Review: Notice of
that the product was being Closed Meetings
discontinued. In a contemporaneous Associate Commissioner for Policy.
notice, FDA is announcing its [FR Doc. 2015–14144 Filed 6–9–15; 8:45 am] Pursuant to section 10(d) of the
determination that the product was BILLING CODE 4164–01–P Federal Advisory Committee Act, as
withdrawn from sale for reasons of amended (5 U.S.C. App.), notice is
safety or effectiveness and that FDA will hereby given of the following meetings.
not accept or approve ANDAs that refer DEPARTMENT OF HEALTH AND The meetings will be closed to the
to this drug product. HUMAN SERVICES public in accordance with the
Hospira’s ondansetron HCl Injection provisions set forth in sections
32 mg/50 mL, single IV dose was National Institutes of Health 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
approved in ANDA 077348 on February as amended. The grant applications and
1, 2007. In a letter dated January 31, Center for Scientific Review; Notice of the discussions could disclose
2013, Hospira requested withdrawal of Closed Meeting confidential trade secrets or commercial
ANDA 077348 under 21 CFR property such as patentable material,
Pursuant to section 10(d) of the
314.150(d), and waived its opportunity and personal information concerning
Federal Advisory Committee Act, as
for a hearing provided under individuals associated with the grant
amended (5 U.S.C. App.), notice is
§ 314.150(a). applications, the disclosure of which
Teva’s ondansetron HCl Injection 32 hereby given of the following meeting.
would constitute a clearly unwarranted
mg/50 mL, single IV dose was approved The meeting will be closed to the invasion of personal privacy.
in ANDA 077480 on November 22, public in accordance with the
Name of Committee: Center for Scientific
2006. In a letter dated November 20, provisions set forth in sections
Review Special Emphasis Panel; Member
2012, Teva requested withdrawal of 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., Conflicts: Infectious, Reproductive, Asthma,
ANDA 077480 under 21 CFR as amended. The grant applications and and Pulmonary Conditions.
314.150(d), and waived its opportunity the discussions could disclose Date: July 2, 2015.
for a hearing provided under confidential trade secrets or commercial Time: 12 p.m. to 3 p.m.
§ 314.150(a). property such as patentable material, Agenda: To review and evaluate grant
Bedford’s ondansetron HCl Injection and personal information concerning applications.
32 mg/50 mL, single IV dose was individuals associated with the grant Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
approved in ANDA 078291 on April 13, applications, the disclosure of which
(Telephone Conference Call).
2009. In a letter dated April 4, 2014, would constitute a clearly unwarranted Contact Person: Ellen K. Schwartz, Ed.D.,
Bedford requested withdrawal of ANDA invasion of personal privacy. Scientific Review Officer, Center for
078291, under 21 CFR 314.150(d), and Name of Committee: Center for Scientific Scientific Review, National Institutes of
waived its opportunity for a hearing Review Special Emphasis Panel, Member Health, 6701 Rockledge Drive, Room 3144,
provided under § 314.150(a). Conflict: Dry Eye and Lacrimal Gland. MSC 7770, Bethesda, MD 20892, 301–828–
Claris’s ondansetron HCl Injection 32 Date: June 15, 2015. 6146, schwarel@mail.nih.gov.
mg/50 mL, single IV dose, was approved Time: 4:00 p.m. to 6:00 p.m. Name of Committee: Center for Scientific
asabaliauskas on DSK5VPTVN1PROD with NOTICES
in ANDA 078308 on March 17, 2008. In Agenda: To review and evaluate grant Review Special Emphasis Panel;
a letter dated November 16, 2012, applications. Bioengineering Sciences Member Conflict.
Place: National Institutes of Health, 6701 Date: July 7–9, 2015.
through its U.S. agent, CUSTOpharm,
Rockledge Drive, Bethesda, MD 20892, Time: 12 p.m. to 5 p.m.
Inc., Claris requested withdrawal of (Telephone Conference Call). Agenda: To review and evaluate grant
ANDA 078308 under 21 CFR Contact Person: Alessandra C Rovescalli, applications.
314.150(d), and waived its opportunity Ph.D., Scientific Review Officer, National Place: National Institutes of Health, 6701
for a hearing provided under Institutes of Health, Center for Scientific Rockledge Drive, Bethesda, MD 20892,
§ 314.150(a). Review, 6701 Rockledge Drive, Rm 5205 (Virtual Meeting).
VerDate Sep<11>2014 16:46 Jun 09, 2015 Jkt 235001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1](https://thefederalregister.org/doc/80_FR_33077/page/2.svg)
Document Created: 2015-12-15 15:16:51
Document Modified: 2015-12-15 15:16:51
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Effective June 10, 2015. | |
| 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. | |
| FR Citation | 80 FR 32966 |
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