80 FR 32962 - Determination That Ondansetron (Ondansetron Hydrochloride) Injection, USP in PL 2408 Plastic Container, 32 Milligrams in 50 Milliliters, Was Withdrawn From Sale for Reasons of Safety or Effectiveness
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 | 32962-32962 | |
| FR Document | 2015-14145 |
[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)] [Notices] [Page 32962] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-14145] [[Page 32962]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-1663] Determination That Ondansetron (Ondansetron Hydrochloride) Injection, USP in PL 2408 Plastic Container, 32 Milligrams in 50 Milliliters, Was Withdrawn From Sale for Reasons of Safety or Effectiveness AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) has determined that Ondansetron (ondansetron hydrochloride (HCl)) Injection, USP in PL 2408 Plastic Container, 32 milligrams (mg) in 50 milliliters (mL), single intravenous (IV) dose, was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for Ondansetron (ondansetron HCl) Injection, USP in PL 2408 Plastic Container, 32 mg/50 mL, single IV dose. 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: In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show among other things that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the ``listed drug,'' which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the ``Approved Drug Products With Therapeutic Equivalence Evaluations,'' which is known generally as the ``Orange Book.'' Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). A person may petition the Agency to determine, or the Agency may determine on its own initiative, whether a listed drug was withdrawn from sale for reasons of safety or effectiveness. This determination may be made at any time after the drug has been withdrawn from sale but must be made prior to approving an ANDA that refers to the listed drug (21 CFR 314.161). FDA may not approve an ANDA that does not refer to a listed drug. Ondansetron (ondansetron HCl) Injection, USP in PL 2408 Plastic Container, 32 mg/50 mL, single IV dose, is the subject of NDA 021915, held by Baxter Healthcare Corporation (Baxter), and initially approved on December 27, 2006. The product is indicated for prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy in adult patients. It was approved under the pathway described by section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(2)). Baxter's application relied in part on FDA's finding of safety and effectiveness for ZOFRAN, NDA 020007, held by GlaxoSmithKline (GSK). In September 2011, FDA issued a Drug Safety Communication noting concerns that the 32 mg single IV dose of ZOFRAN, NDA 020007, and generic versions of that product could increase the risk of abnormal changes in the electrical activity of the heart, which could result in a potentially fatal abnormal heart rhythm. Specifically, the Agency noted that the 32 mg single IV dose of ondansetron could cause QT prolongation, which can lead to a serious and sometimes fatal heart rhythm called Torsades de Pointes. At FDA's request, GSK conducted a study to assess that risk. That study identified a significant QT prolongation effect in connection with the 32 mg single IV dose of Ondansetron. Based on this data, FDA approved GSK's supplemental application to remove the 32 mg single IV dose information from the labeling for ZOFRAN and has worked with manufacturers of all 32 mg, single IV dose ondansetron products to have them removed from the market. In a letter dated September 5, 2012, Baxter notified FDA that Ondansetron (ondansetron HCl) Injection, USP in PL 2408 Plastic Container, 32 mg/50 mL, single IV dose, was being discontinued, and FDA moved the drug product to the ``Discontinued Drug Product List'' section of the Orange Book. In a letter dated November 27, 2012, Baxter requested withdrawal of NDA 021915 for Ondansetron (ondansetron HCl) Injection, USP in PL 2408 Plastic Container, 32 mg/50 mL, single IV dose. In a contemporaneous notice, FDA is announcing that it is withdrawing approval of NDA 021915. We have carefully reviewed our files for records concerning the withdrawal of Ondansetron (ondansetron HCl) Injection, USP in PL 2408 Plastic Container, 32 mg/50 mL, single IV dose, from sale. We have also evaluated relevant literature and data. FDA has determined under Sec. Sec. 314.161 and 314.162(a)(2), that Ondansetron (ondansetron HCl) Injection, USP in PL 2408 Plastic Container, 32 mg/50 mL, single IV dose, was withdrawn from sale for reasons of safety. Accordingly, the Agency will remove Ondansetron (ondansetron HCl) Injection, USP in PL 2408 Plastic Container, 32 mg/50 mL, single IV dose, from the list of drug products published in the Orange Book. FDA will not accept or approve ANDAs that refer to this drug product. Dated: June 4, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015-14145 Filed 6-9-15; 8:45 am] BILLING CODE 4164-01-P
![32962 Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices
DEPARTMENT OF HEALTH AND Agency withdraws or suspends ‘‘Discontinued Drug Product List’’
HUMAN SERVICES approval of the drug’s NDA or ANDA section of the Orange Book. In a letter
for reasons of safety or effectiveness or dated November 27, 2012, Baxter
Food and Drug Administration if FDA determines that the listed drug requested withdrawal of NDA 021915
was withdrawn from sale for reasons of for Ondansetron (ondansetron HCl)
[Docket No. FDA–2015–N–1663]
safety or effectiveness (21 CFR 314.162). Injection, USP in PL 2408 Plastic
Determination That Ondansetron A person may petition the Agency to Container, 32 mg/50 mL, single IV dose.
(Ondansetron Hydrochloride) Injection, determine, or the Agency may In a contemporaneous notice, FDA is
USP in PL 2408 Plastic Container, 32 determine on its own initiative, whether announcing that it is withdrawing
Milligrams in 50 Milliliters, Was a listed drug was withdrawn from sale approval of NDA 021915.
Withdrawn From Sale for Reasons of for reasons of safety or effectiveness. We have carefully reviewed our files
This determination may be made at any for records concerning the withdrawal
Safety or Effectiveness
time after the drug has been withdrawn of Ondansetron (ondansetron HCl)
AGENCY: Food and Drug Administration, from sale but must be made prior to Injection, USP in PL 2408 Plastic
HHS. approving an ANDA that refers to the Container, 32 mg/50 mL, single IV dose,
ACTION: Notice. listed drug (21 CFR 314.161). FDA may from sale. We have also evaluated
not approve an ANDA that does not relevant literature and data. FDA has
SUMMARY: The Food and Drug refer to a listed drug. determined under §§ 314.161 and
Administration (FDA) has determined Ondansetron (ondansetron HCl) 314.162(a)(2), that Ondansetron
that Ondansetron (ondansetron Injection, USP in PL 2408 Plastic (ondansetron HCl) Injection, USP in PL
hydrochloride (HCl)) Injection, USP in Container, 32 mg/50 mL, single IV dose, 2408 Plastic Container, 32 mg/50 mL,
PL 2408 Plastic Container, 32 is the subject of NDA 021915, held by single IV dose, was withdrawn from sale
milligrams (mg) in 50 milliliters (mL), Baxter Healthcare Corporation (Baxter), for reasons of safety.
single intravenous (IV) dose, was and initially approved on December 27, Accordingly, the Agency will remove
withdrawn from sale for reasons of 2006. The product is indicated for Ondansetron (ondansetron HCl)
safety or effectiveness. The Agency will prevention of nausea and vomiting Injection, USP in PL 2408 Plastic
not accept or approve abbreviated new associated with initial and repeat Container, 32 mg/50 mL, single IV dose,
drug applications (ANDAs) for courses of emetogenic cancer from the list of drug products published
Ondansetron (ondansetron HCl) chemotherapy in adult patients. It was in the Orange Book. FDA will not accept
Injection, USP in PL 2408 Plastic approved under the pathway described or approve ANDAs that refer to this
Container, 32 mg/50 mL, single IV dose. by section 505(b)(2) of the Federal Food, drug product.
Drug, and Cosmetic Act (21 U.S.C.
FOR FURTHER INFORMATION CONTACT: Dated: June 4, 2015.
355(b)(2)). Baxter’s application relied in
Emily Helms Williams, Center for Drug Leslie Kux,
part on FDA’s finding of safety and
Evaluation and Research, Food and
effectiveness for ZOFRAN, NDA Associate Commissioner for Policy.
Drug Administration, 10903 New
020007, held by GlaxoSmithKline [FR Doc. 2015–14145 Filed 6–9–15; 8:45 am]
Hampshire Ave., Bldg. 51, Rm. 6280,
(GSK). BILLING CODE 4164–01–P
Silver Spring, MD 20993–0002, 301– In September 2011, FDA issued a
796–3381. Drug Safety Communication noting
SUPPLEMENTARY INFORMATION: In 1984, concerns that the 32 mg single IV dose DEPARTMENT OF HEALTH AND
Congress enacted the Drug Price of ZOFRAN, NDA 020007, and generic HUMAN SERVICES
Competition and Patent Term versions of that product could increase
Restoration Act of 1984 (Pub. L. 98–417) the risk of abnormal changes in the Food and Drug Administration
(the 1984 amendments), which electrical activity of the heart, which [Docket No. FDA–2014–N–0554]
authorized the approval of duplicate could result in a potentially fatal
versions of drug products under an abnormal heart rhythm. Specifically, the Agency Information Collection
ANDA procedure. ANDA applicants Agency noted that the 32 mg single IV Activities; Announcement of Office of
must, with certain exceptions, show dose of ondansetron could cause QT Management and Budget Approval
among other things that the drug for prolongation, which can lead to a Comparative Price Information in
which they are seeking approval serious and sometimes fatal heart Direct-to-Consumer and Professional
contains the same active ingredient in rhythm called Torsades de Pointes. At Prescription Drug Advertisements
the same strength and dosage form as FDA’s request, GSK conducted a study
the ‘‘listed drug,’’ which is a version of to assess that risk. That study identified AGENCY: Food and Drug Administration,
the drug that was previously approved. a significant QT prolongation effect in HHS.
ANDA applicants do not have to repeat connection with the 32 mg single IV ACTION: Notice.
the extensive clinical testing otherwise dose of Ondansetron. Based on this
necessary to gain approval of a new data, FDA approved GSK’s SUMMARY: The Food and Drug
drug application (NDA). supplemental application to remove the Administration (FDA) is announcing
The 1984 amendments include what 32 mg single IV dose information from that a collection of information entitled
is now section 505(j)(7) of the Federal the labeling for ZOFRAN and has ‘‘Comparative Price Information in
Food, Drug, and Cosmetic Act (21 U.S.C. worked with manufacturers of all 32 mg, Direct-to-Consumer and Professional
asabaliauskas on DSK5VPTVN1PROD with NOTICES
355(j)(7)), which requires FDA to single IV dose ondansetron products to Prescription Drug Advertisements’’ has
publish a list of all approved drugs. have them removed from the market. been approved by the Office of
FDA publishes this list as part of the In a letter dated September 5, 2012, Management and Budget (OMB) under
‘‘Approved Drug Products With Baxter notified FDA that Ondansetron the Paperwork Reduction Act of 1995.
Therapeutic Equivalence Evaluations,’’ (ondansetron HCl) Injection, USP in PL FOR FURTHER INFORMATION CONTACT: FDA
which is known generally as the 2408 Plastic Container, 32 mg/50 mL, PRA Staff, Office of Operations, Food
‘‘Orange Book.’’ Under FDA regulations, single IV dose, was being discontinued, and Drug Administration, 8455
drugs are removed from the list if the and FDA moved the drug product to the Colesville Rd., COLE–14526, Silver
VerDate Sep<11>2014 16:46 Jun 09, 2015 Jkt 235001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\10JNN1.SGM 10JNN1](https://thefederalregister.org/doc/80_FR_33073/page/1.svg)
Document Created: 2015-12-15 15:17:16
Document Modified: 2015-12-15 15:17:16
| 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. | |
| 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 32962 |
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