Tramadol ANDAs are “approvable”
Executive Summary
Teva, Apotex and Watson generics of J&J's Ultram (tramadol) are "approvable" at FDA while the agency resolves whether patent-protected sections of Ultram labeling are essential for safety and efficacy of the pain relief agent. In a November citizen petition, Apotex argued that the titration dosing schedules added to labeling were not prompted by safety or efficacy concerns (1"The Pink Sheet" Nov. 19, 2001, p. 14). Par also has an ANDA pending...
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