[Federal Register Volume 74, Number 70 (Tuesday, April 14, 2009)]
[Notices]
[Pages 17196-17197]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-8524]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-P-0250] (formerly Docket No. 2007P-0341)


Determination That ZOMETA (Zoledronic Acid for Injection), 
Equivalent to 4 Milligrams Base Per Vial, Lyophilized Powder 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Injection, Was Not Withdrawn From Sale for Reasons of Safety or 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 
ZOMETA (zoledronic acid for injection), equivalent to (EQ) 4 milligrams 
(mg) base/vial, lyophilized powder for injection, was not withdrawn 
from sale for reasons of safety or effectiveness. This determination 
will allow FDA to approve abbreviated new drug applications (ANDAs) for 
zoledronic acid lyophilized powder for injection, 4-mg base/vial.

FOR FURTHER INFORMATION CONTACT: Nancy Boocker, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, rm. 6244, Silver Spring, MD 20993-0002, 301-
796-3601.

SUPPLEMENTARY INFORMATION: In 1984, Congress enacted the Drug Price 
Competition and Patent Term Restoration Act of 1984 (Public Law 98-417) 
(the 1984 amendments), which authorized the approval of duplicate 
versions of drug products approved under an ANDA procedure. ANDA 
sponsors 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. Sponsors of ANDAs 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 generally known as the ``Orange 
Book.'' Under FDA regulations, drugs are withdrawn 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).
    Under 21 CFR 314.161(a)(1), the agency must determine whether a 
listed drug was withdrawn from sale for reasons of safety or 
effectiveness before an ANDA that refers to that listed drug may be 
approved. FDA may not approve an ANDA that does not refer to a listed 
drug.
    ZOMETA (zoledronic acid for injection), EQ 4-mg base/vial, 
lyophilized powder for injection, is the subject of approved NDA 21-223 
held by Novartis Pharmaceuticals Corp. (Novartis). Zoledronic acid, 
lyophilized powder for injection, EQ 4-mg base/vial, is indicated for 
treatment of hypercalcemia of malignancy. It also is indicated for the 
treatment of patients with multiple myeloma and patients with 
documented bone metastases from solid tumors, in conjunction with 
standard antineoplastic therapy. Novartis ceased manufacturing ZOMETA 
(zoledronic acid for injection), EQ 4 mg-base/vial, lyophilized powder 
for injection, in May 2003. On September 13, 2007, Kendle 
International, on behalf of Sun Pharmaceutical Industries Ltd., 
submitted a citizen petition (Docket No. 2007P-0341/CP1), under 21 CFR 
10.30, requesting that the agency determine whether zoledronic acid 
lyophilized powder for injection, EQ 4-mg base/vial, was withdrawn from 
sale for reasons of safety or effectiveness.
    The agency has determined that ZOMETA (zoledronic acid for 
injection), EQ 4-mg base/vial, lyophilized powder for injection, was 
not withdrawn from sale for reasons of safety or effectiveness. The 
petitioner has identified no data or other information suggesting that 
zoledronic acid lyophilized powder for injection, 4-mg base/vial, was 
withdrawn from sale as a result of safety or effectiveness concerns. 
FDA's independent evaluation of relevant information has uncovered no 
information that would indicate this product was withdrawn for reasons 
of safety or effectiveness.
    After considering the citizen petition and reviewing agency 
records, FDA determines that for the reasons outlined previously, 
ZOMETA (zoledronic acid for injection), EQ 4-mg base/vial, lyophilized 
powder for injection, was not withdrawn from sale for reasons of safety 
or effectiveness. Accordingly, the agency will continue to list ZOMETA 
(zoledronic acid for injection), 4-mg base/vial, lyophilized powder for 
injection, 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 
ZOMETA (zoledronic acid for injection), EQ 4-mg base/vial, lyophilized 
powder for injection, may be approved by the agency as long as they 
meet all relevant legal and regulatory requirements for the approval of 
ANDAs. If FDA determines that the labeling of this drug product should 
be revised to meet current standards, the agency will advise ANDA 
applicants to submit such labeling.


[[Page 17197]]


    Dated: March 7, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8524 Filed 4-13-09; 8:45 am]
BILLING CODE 4160-01-S