Bayer Pharma Gets CDSCO Panel Nod To Update Prescribing Information of Anti-cancer Drug Darolutamide
New Delhi: Bayer Pharma has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to update the prescribing information of the anti-cancer drug Darolutamide 300mg.
This came after the firm presented the proposal for updated prescribing information for Darolutamide 300 mg film-coated tablets (Nubeqa), changes version 4 to 5 (version No NU_2023_02 dated 24 Feb 2023 based on the updated company core data sheet (CCDS).
Darolutamide is an androgen receptor antagonist used for castration-resistant, non-metastatic prostate cancer, and metastatic hormone-sensitive prostate cancer.
Darolutamide competitively inhibits androgens from binding to their receptors, inhibiting AR nuclear translocation, as well as AR-mediated transcription. The end result of these processes is a decrease in prostate cancer cell proliferation and tumor size. Its main metabolite, keto-darolutamide, shows similar pharmacological activity to the parent drug, darolutamide.
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