Alembic Pharmaceuticals Limited receives USFDA Tentative Approval for Darolutamide Tablets, 300 mg.
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Alembic Pharmaceuticals has received tentative approval from the USFDA for its generic Darolutamide Tablets, 300 mg. The drug is equivalent to Bayer's Nubeqa and treats prostate cancer conditions including non-metastatic and metastatic castration-resistant prostate cancer. The US market for this drug is estimated at US$ 3,155 million annually. With this approval, Alembic has now received 238 ANDA approvals from USFDA cumulatively.
This approval opens a significant revenue opportunity in the large US prostate cancer market. The tentative approval signals Alembic's continued ability to secure US regulatory clearances, which could positively influence investor sentiment.