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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)

# AGENCY:

Food and Drug Administration, HHS.

# ACTION:

Notice.

# 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acid for injection), equivalent to (EQ) 4 milligrams (mg) base/vial, lyophilized powder for injection, was not withdrawn from sale for reasons of safety or effectiveness.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 Under FDA regulations, drugs are withdrawn from the list if the agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

Under 21 CFR 314.161(a)(1), the agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved.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.

      ( print 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