Alembic Pharma Gets USFDA Tentative Nod for Nubeqa Generic Darolutamide
New Delhi: Alembic Pharmaceuticals has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Darolutamide Tablets, 300 mg, the company announced on Tuesday.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD) Nubeqa of Bayer HealthCare Pharmaceuticals.
Darolutamide is an androgen receptor inhibitor indicated for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC), metastatic castration-sensitive prostate cancer (mCSPC), and mCSPC in combination with docetaxel.
According to IQVIA data cited by the company, Darolutamide Tablets, 300 mg, had an estimated market size of USD 3,155 million for the 12 months ending March 2026.
With this approval, Alembic now has a cumulative total of 238 ANDA approvals from the USFDA, including 219 final approvals and 19 tentative approvals.
Also Read: Alembic Secures USFDA Approval for Gilenya Generic
Headquartered in India, Alembic Pharmaceuticals is a vertically integrated pharmaceutical company engaged in the development, manufacturing and marketing of generic medicines globally. The company’s manufacturing facilities are approved by several international regulatory authorities, including the USFDA.
