USFDA14 May 2026, 10:10 am
Alembic Pharma Gets USFDA Nod for Darolutamide Tablets
AI Summary
Alembic Pharmaceuticals Ltd. has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Darolutamide Tablets, 300 mg. The ANDA is therapeutically equivalent to Nubeqa Tablets, 300 mg, of Bayer HealthCare Pharmaceuticals Inc. Darolutamide is an androgen receptor inhibitor used to treat specific types of prostate cancer. The estimated market size for Darolutamide Tablets, 300 mg, is US$ 3,155 million for the twelve months ending March 2026, according to IQVIA. Alembic now has a total of 238 ANDA approvals from the USFDA, including 219 final and 19 tentative approvals.
Key Highlights
- Alembic receives USFDA tentative approval for Darolutamide Tablets, 300 mg.
- The drug is therapeutically equivalent to Bayer's Nubeqa Tablets, 300 mg.
- Darolutamide treats non-metastatic and metastatic castration-resistant prostate cancer.
- The market size for Darolutamide Tablets is estimated at US$ 3,155 million.
- Alembic now holds 238 total ANDA approvals from the USFDA.