[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20685-20686]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8819]
-----------------------------------------------------------------------
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Equivalent to 30 Milligrams Base/15 Milliliter, Was Not Withdrawn From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.
-----------------------------------------------------------------------
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was not withdrawn from sale for reasons of safety or effectiveness.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