Renvela is indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
Impax has filed abbreviated new drug application (ANDA) with the FDA containing a paragraph IV certification for a generic version of Renvela.
Impax notified the new drug application holder and patent owner of its paragraph IV certification, after receiving acceptance notice for filing, from the FDA, regarding its ANDA.
Impax stated that following the approval of ANDA by FDA, Global Pharmaceuticals, generic division of Impax, is expected to commercialise the products.