Document ID: FDA-2008-P-0485-0004
Agency: fda
Document Type: Notice
Title: Determinations that Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness: NOVANTRONE (Mitoxantrone Hydrochloride) Injection, Equivalent to 25 Milligrams Base/12.5 Milliliters, etc.
Posted Date: 2011-04-13T04:00Z

[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20685-20686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8819]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-P-0485]

Determination That NOVANTRONE (Mitoxantrone Hydrochloride) 
Injection, Equivalent to 25 Milligrams Base/12.5 Milliliter and 
Equivalent to 30 Milligrams Base/15 Milliliter, Was Not Withdrawn From 
Sale for Reasons of Safety or Effectiveness

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined that 
NOVANTRONE (mitoxantrone hydrochloride) Injection, equivalent to (EQ) 
25 milligrams (mg) base/12.5 milliliters (mL) and EQ 30 mg base/15 mL, 
was not withdrawn from sale for reasons of safety or effectiveness. 
This determination means that FDA will not begin procedures to withdraw 
approval of abbreviated new drug applications (ANDAs) that refer to 
this drug product, and it will allow FDA to continue to approve ANDAs 
that refer to the product as long as they meet relevant legal and 
regulatory requirements.

FOR FURTHER INFORMATION CONTACT: Rachel Bressler, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6302, Silver Spring, MD 20993-0002, 301-
796-4288.

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 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 only clinical data 
required in an ANDA are data to show that the drug that is the subject 
of the ANDA is bioequivalent to the listed drug.
    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 (Sec.  314.161 (21 CFR 314.161)). FDA may not approve an ANDA that 
does not refer to a listed drug.
    NOVANTRONE (mitoxantrone hydrochloride) Injection, EQ 25 mg base/
12.5 mL and EQ 30 mg base/15 mL, is the subject of NDA 19-297, held by 
EMD Serono, and initially approved on December 23, 1987. NOVANTRONE is 
indicated for reducing neurologic disability and/or the frequency of 
clinical relapses in patients with secondary (chronic) progressive, 
progressive relapsing, or worsening relapsing-remitting multiple 
sclerosis (i.e., patients whose neurologic status is significantly 
abnormal between relapses). NOVANTRONE (mitoxantrone hydrochloride) 
Injection, EQ 25 mg base/12.5 mL and EQ 30 mg base/15 mL, is currently 
listed in the ``Discontinued Drug Product List'' section of the Orange 
Book. There are approved ANDAs for NOVANTRONE (mitoxantrone 
hydrochloride) Injection, EQ 25 mg base/12.5 mL and EQ 30 mg base/15 
mL; these ANDAs are listed in the Orange Book.
    Apotex, Inc., submitted a citizen petition dated September 3, 2008 
(Docket No. FDA-2008-P-0485), under 21 CFR 10.30, requesting that the 
Agency determine whether NOVANTRONE (mitoxantrone hydrochloride) 
Injection, 25 mg/12.5 mL and 30 mg/15 mL, was withdrawn from sale for 
reasons of safety or effectiveness.
    After considering the citizen petition and reviewing Agency 
records, FDA has determined under Sec.  314.161 that NOVANTRONE 
(mitoxantrone hydrochloride) Injection, EQ 25 mg base/12.5 mL and EQ 30 
mg base/15 mL, was not withdrawn for reasons of safety or 
effectiveness. The petitioner has identified no data or other 
information suggesting that NOVANTRONE

[[Page 20686]]

(mitoxantrone hydrochloride) Injection, EQ 25 mg base/12.5 mL and EQ 30 
mg base/15 mL, was withdrawn for reasons of safety or effectiveness. We 
have carefully reviewed our files for records concerning the withdrawal 
of NOVANTRONE (mitoxantrone hydrochloride) Injection, EQ 25 mg base/
12.5 mL and EQ 30 mg base/15 mL, from sale. We have also independently 
evaluated relevant literature and data for possible postmarketing 
adverse events. We have found no information that would indicate that 
this product was withdrawn from sale for reasons of safety or 
effectiveness.
    Accordingly, the Agency will continue to list NOVANTRONE 
(mitoxantrone hydrochloride) Injection, EQ 25 mg base/12.5 mL and EQ 30 
mg base/15 mL, in the ``Discontinued Drug Product List'' section of the 
Orange Book. The ``Discontinued Drug Product List'' delineates, among 
other items, drug products that have been discontinued from marketing 
for reasons other than safety or effectiveness. FDA will not begin 
procedures to withdraw approval of approved ANDAs that refer to 
NOVANTRONE Injection. Additional ANDAs for mitoxantrone hydrochloride 
injection, EQ 25 mg base/12.5 mL and EQ 30 mg base/15 mL, may also be 
approved by the Agency as long as they meet all other legal and 
regulatory requirements for the approval of ANDAs. If FDA determines 
that labeling for this drug product should be revised to meet current 
standards, the Agency will advise ANDA applicants to submit such 
labeling.

    Dated: April 6, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-8819 Filed 4-12-11; 8:45 am]
BILLING CODE 4160-01-P