FDA has reviewed its records and, under § 314.161, has determined that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, was not withdrawn from sale for reasons of safety or effectiveness. The petitioner identified no data or other information suggesting that DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, was withdrawn for reasons of safety or effectiveness.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data for possible postmarketing adverse events and has found no information that would indicate that this product was withdrawn from sale for reasons of safety or effectiveness.
Accordingly, the agency will continue to list DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, 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 DECA-DURABOLIN (nandrolone decanoate) Injection, 200 mg/mL, 1 mL, 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 this drug product should be revised to meet current standards, the agency will advise ANDA applicants to submit such labeling.