2011-5947. Determination that ROCEPHIN (Ceftriaxone Sodium) Injection, 250 Milligrams, 500 Milligrams, 1 Gram, 2 Grams, and 10 Grams Base/Vial, Approved Under New Drug Application 050585, Were Not Withdrawn From Sale for Reasons of Safety or ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) has determined ROCEPHIN (ceftriaxone sodium) Injection, 250 milligrams (mg), 500mg, 1 gram (g), 2g, and 10g base/vial, approved under new drug application (NDA) 050585, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for any of these products if all other legal and regulatory requirements are met.

FOR FURTHER INFORMATION CONTACT:

Patrick Raulerson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6368, Silver Spring, MD 20993-0002, 301-796-3522.

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 approved 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 an 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, a drug is 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approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). Under § 314.161(a)(1) (21 CFR 314.161(a)(1)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness before an ANDA that refers to that listed drug may be approved.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.

ROCEPHIN (ceftriaxone sodium) Injection, 250mg, 500mg, 1g, 2g, and 10g base/vial, are the subject of NDA 050585 held by F. Hoffman-La Roche Ltd. (La Roche). ROCEPHIN (ceftriaxone sodium) is a semisynthetic cephalosporin antibiotic for intravenous or intramuscular administration and is indicated for the treatment of certain infections as described in the labeling. The drug products approved under NDA 050585 are currently listed in the “Discontinued Drug Product List” section of the Orange Book.

Steven H. Sklar of Leydig, Voit & Mayer, Ltd., submitted a citizen petition dated April 3, 2009 (Docket No. FDA-2009-P-0177), under 21 CFR 10.30, requesting that FDA determine that ROCEPHIN (ceftriaxone sodium) Injection, 250mg, 500mg, 1g, 2g, and 10g base/vial, approved under NDA 050585, were withdrawn from sale for reasons other than safety or effectiveness.

After considering the citizen petition and reviewing Agency records, FDA has determined under § 314.161 that ROCEPHIN (ceftriaxone sodium) Injection, 250mg, 500mg, 1g, 2g, and 10g base/vial, approved under NDA 050585, were not withdrawn from sale for reasons of safety or effectiveness. The petitioner has identified no data or other information suggesting that these products were withdrawn from sale for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of these products from sale. We have also independently evaluated the relevant literature and data for possible postmarketing adverse events. We have found no information that would indicate that any of these products were withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list ROCEPHIN (ceftriaxone sodium) Injection, 250mg, 500mg, 1g, 2g, and 10g base/vial, approved under NDA 050585, 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 withdrawn from sale for reasons other than safety or effectiveness. ANDAs that refer to any of the products described in this notice may be approved by FDA as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for any of these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.

Dated: March 9, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.