Various generic players have received final approval to market anti-cancer formulation Bicalutamide (Casodex) 50 mg tablets after the expiry of product patent US4636505 (Expiry: Apr 1, 2009) in USA.
Following generic players have got final approval from USFDA:
1. Teva
2. Synthon
3. Kudoco Ireland
4. Sandoz
5. Accord Healthcare
6. Zydus Pharma
7. Sun Pharma
8. Mylan
The generic Bicalutamide (Casodex) 50 mg tablets are bioequivalent to Casodex® tablets from AstraZeneca. As per IMS, Casodex® tablets have annual sales of approximately USD 314 million in the US.
Earlier, innovator has got approval from USFDA to market this product on October 4, 1995.
Bicalutamide (Casodex) 50 mg tablets are an androgen receptor inhibitor for the treatment of Stage D2 metastatic carcinoma of the prostate.
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