2010-16438. Determination That ACTONEL (Risendronate Sodium) Tablets, 75 Milligrams, and ACTONEL WITH CALCIUM (Risendronate Sodium and Calcium Carbonate (Copackaged)) Tablets, 35 Milligrams/500 Milligrams, Were Not Withdrawn From Sale for Reasons of ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the determination that ACTONEL (risendronate sodium) Tablets, 75 milligrams (mg), and ACTONEL WITH CALCIUM (risendronate sodium and calcium carbonate (copackaged)) Tablets, 35 mg/500 mg, were not withdrawn from sale for reasons of safety or effectiveness.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:

Jane Baluss, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6362, Silver Spring, MD 20993-0002, 301-796-3469.

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 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of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162). 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.

Lachman Consultant Services submitted a petition dated January 12, 2010 (FDA-2010-P-0027), requesting a determination that ACTONEL (risendronate sodium) Tablets, 75 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. ACTONEL (risendronate sodium) Tablets, 75 mg, is the subject of NDA 20-835, held by Warner Chilcott and initially approved on April 16, 2004. ACTONEL (risendronate sodium) Tablets, 75 mg, is indicated for the treatment of postmenopausal osteoporosis in men, and Paget's disease in men and women.

In a separate citizen petition dated January 20, 2010 (FDA-2010-P-0051), Lachman Consultant Services requested a determination that ACTONEL WITH CALCIUM (risendronate sodium and calcium carbonate (copackaged)) Tablets, 35/500 mg, was not withdrawn from sale for reasons of safety or effectiveness. In another separate petition dated January 21, 2010, EAS Consulting Group, LLC, requested the same determination on behalf of Aurobindo Pharmaceuticals. ACTONEL WITH CALCIUM (risendronate sodium and calcium carbonate (copackaged)) Tablets, 35/500 mg, is the subject of NDA 21-823, held by Procter & Gamble and initially approved on August 12, 2005. ACTONEL WITH CALCIUM (risendronate sodium and calcium carbonate (copackaged)) Tablets, 35/500 mg, is indicated for the treatment of postmenopausal osteoporosis.

FDA has reviewed its records and, under § 314.161, has determined that neither ACTONEL (risendronate sodium) Tablets, 75 mg, nor ACTONEL WITH CALCIUM (risendronate sodium and calcium carbonate (copackaged)) Tablets, 35/500 mg, was withdrawn from sale for reasons of safety or effectiveness. None of the petitions identified any data or other information suggesting that either of the products named in the petitions was withdrawn for reasons of safety or effectiveness. FDA has independently evaluated relevant literature and data for possible postmarketing adverse events and has found no information that would indicate that either product was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will continue to list ACTONEL (risendronate sodium) Tablets, 75 mg, and ACTONEL WITH CALCIUM (risendronate sodium and calcium carbonate (copackaged)) Tablets, 35/500 mg, 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 ACTONEL (risendronate sodium) Tablets, 75 mg, or ACTONEL WITH CALCIUM (risendronate sodium and calcium carbonate (copackaged)) Tablets, 35/500 mg, may be approved by the agency if all other legal and regulatory requirements for the approval of ANDAs are met. If FDA determines that labeling for either or both of these drug products should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling.

Dated: June 30, 2010.

Leslie Kux,

Acting Assistant Commissioner for Policy.