Use of generic alendronate in the treatment of osteoporosis

Abstract

In summary, NOFSA wishes to express its concern that available information on generic alendronate may not be sufficient to determine its long-term efficacy and safety. In particular, NOFSA's concerns relate to: (i) the extremely poor intestinal absorption and rapid skeletal uptake of bisphosphonates, which complicate their accurate quantification in blood (therefore necessitating assays on urine specimens) and the correct interpretation of bioequivalence studies; and (ii) their pre-systemic gastrointestinal side-effect profile (which is not influenced by bioequivalence).