[Federal Register Volume 78, Number 150 (Monday, August 5, 2013)]
[Notices]
[Pages 47321-47322]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-18731]
[[Page 47321]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-P-0241]
Determination That CYTOXAN (Cyclophosphamide) for Injection 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Not Withdrawn From Sale for Reasons of Safety or Effectiveness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
CYTOXAN (cyclophosphamide) for Injection (lyophilized formulations),
100 milligrams (mg)/vial, 200 mg/vial, 500 mg/vial, 1 gram (g)/vial,
and 2 g/vial, and CYTOXAN (cyclophosphamide) for Injection (non-
lyophilized formulations), 100 mg/vial and 200 mg/vial, were not
withdrawn from sale for reasons of safety or effectiveness. This
determination will allow FDA to approve abbreviated new drug
applications (ANDAs) for these products, if all other legal and
regulatory requirements are met.
FOR FURTHER INFORMATION CONTACT: Christine Kirk, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6280, Silver Spring, MD 20993-0002, 301-
796-2465.
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 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.
CYTOXAN (cyclophosphamide) for Injection (lyophilized
formulations), 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2
g/vial, and CYTOXAN (cyclophosphamide) for Injection, 100 mg/vial and
200 mg/vial, are the subject of NDA 012142, held by Baxter Healthcare,
and initially approved on November 16, 1959. CYTOXAN for Injection is
an alkylating drug product indicated for treatment of malignant
lymphomas, Hodgkin's disease, lymphocytic lymphoma, mixed-cell type
lymphoma, histiocytic lymphoma, Burkitt's lymphoma, multiple myeloma,
leukemias, mycosis fungoides, neuroblastoma, adenocarcinoma of ovary,
retinoblastoma, breast carcinoma, and minimal change nephrotic syndrome
in pediatric patients.
CYTOXAN (cyclophosphamide) for Injection (lyophilized
formulations), 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2
g/vial, and CYTOXAN (cyclophosphamide) for Injection, 100 mg/vial and
200 mg/vial, are currently listed in the ``Discontinued Drug Product
List'' section of the Orange Book.
Foley & Lardner LLP submitted a citizen petition dated February 26,
2013 (Docket No. FDA-2013-P-0241), under 21 CFR 10.30, requesting that
the Agency determine whether CYTOXAN (cyclophosphamide) for Injection
(lyophilized formulations), 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial, were voluntarily withdrawn or withheld from sale
for reasons of safety or effectiveness. Although the citizen petition
did not address the non-lyophilized 100 mg/vial and 200 mg/vial
formulations, those strengths have also been discontinued. On our own
initiative, we have also determined whether those strengths were
withdrawn for safety or effectiveness reasons.
After considering the citizen petition and reviewing Agency records
and based on the information we have at this time, FDA has determined
under Sec. 314.161 that CYTOXAN (cyclophosphamide) for Injection
(lyophilized formulations), 100mg/vial, 200mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial, and CYTOXAN (cyclophosphamide) for Injection, 100
mg/vial and 200 mg/vial, were not withdrawn for reasons of safety or
effectiveness. The petitioner has identified no data or other
information suggesting that CYTOXAN (cyclophosphamide) for Injection
(lyophilized formulations), 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial, or CYTOXAN (cyclophosphamide) for Injection, 100
mg/vial and 200 mg/vial, were withdrawn for reasons of safety or
effectiveness. We have carefully reviewed our files for records
concerning the withdrawal of CYTOXAN (cyclophosphamide) for Injection
(lyophilized formulations), 100 mg/vial, 200 mg/vial, 500 mg/vial, 1 g/
vial, and 2 g/vial, and CYTOXAN (cyclophosphamide) for Injection, 100
mg/vial and 200 mg/vial, 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
these products were withdrawn from sale for reasons of safety or
effectiveness.
Accordingly, the Agency will continue to list CYTOXAN
(cyclophosphamide) for Injection (lyophilized formulations), 100 mg/
vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2 g/vial, and CYTOXAN
(cyclophosphamide) for Injection, 100 mg/vial and 200 mg/vial, 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. ANDAs that refer to CYTOXAN
(cyclophosphamide) for Injection (lyophilized formulations), 100 mg/
vial, 200 mg/vial, 500 mg/vial, 1 g/vial, and 2 g/vial, or CYTOXAN
(cyclophosphamide) for Injection, 100 mg/vial and 200 mg/vial, may 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 these drug products should be revised to meet current
standards, the Agency will advise ANDA applicants to submit such
labeling.
[[Page 47322]]
Dated: July 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-18731 Filed 8-2-13; 8:45 am]
BILLING CODE 4160-01-P