Sun Pharmaceutical Industries announced that USFDA has granted its subsidiary an approval for an Abbreviated New Drug Application (ANDA) for generic Casodex Bicalutamide tablets.
These bicalutamide tablets, USP 50 milligram are therapeutically equivalent to Casodex tablets from AstraZeneca Casodex tablets have annual sales of approximately $314 million in the US.
Bicalutamide tablets are an androgen receptor inhibitor indicated for use in combination therapy with a lutenizing harmone-releasing harmone (LHRH) analog for treatment of stage D2 metastatic carcinoma of the prostate.