The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Stalevo Tablets
The approval follows the pivotal Phase III ARANOTE trial, which demonstrated that darolutamide plus ADT cut the risk of radiological progression or death by 46% compared to placebo plus ADT
The antibody was designed and developed at Abzena’s Cambridge, UK,
European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)
Orion will be the exclusive partner for the distribution, marketing, and sales of Shilpa's Recombinant Human Albumin in Europe
NUBEQA is currently indicated for the treatment of adult patients with mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC)
An investigational CYP11A1 Inhibitor, for the treatment of metastatic castration-resistant prostate cancer
The products are slated to be manufactured at the Ankleshwar facility and is expected to start contributing meaningfully to the revenue from FY25
The product is expected to start contributing meaningfully to the revenue from FY25
New subgroup analysis from Phase III ARASENS trial shows that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel increased overall survival (OS)
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