Alembic Pharma Share in Focus After USFDA Tentative Approval for Generic Prostate Cancer Drug

Alembic Pharmaceuticals on Thursday announced that it has received tentative approval from the US Food & Drug Administration (USFDA) for its generic version of Darolutamide tablets, a drug indicated for the treatment of prostate cancer.

The approval relates to the company’s Abbreviated New Drug Application (ANDA) for Darolutamide tablets in the 300 mg strength.

Tentative Approval for Generic Darolutamide Tablets

According to the company, the approved ANDA is therapeutically equivalent to Nubeqa Tablets, 300 mg, marketed by Bayer HealthCare Pharmaceuticals.

Darolutamide is prescribed for adult patients with certain types of prostate cancer and is used in combination with docetaxel as part of treatment therapy.

Focus on Expanding US Generics Portfolio

The tentative approval marks another addition to Alembic Pharmaceuticals’ growing portfolio of generic products in the United States market.

Indian pharmaceutical companies continue to focus on regulated markets such as the US through product launches and approvals in specialised therapeutic segments, including oncology treatments.

Alembic Pharmaceuticals Share Price Performance

Shares of Alembic Pharmaceuticals were trading lower. The stock traded at ₹780.85, down ₹4.85 or 0.62%, compared with the previous closing price of ₹785.70.

Read More: Goldline Pharmaceutical IPO Allotment Status.

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Conclusion

Alembic Pharmaceuticals has received tentative USFDA approval for its generic Darolutamide tablets used in prostate cancer treatment. The development supports the company’s efforts to expand its presence in the US generics market, particularly in specialised therapy areas.

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