Gland Pharma Gets US FDA Nod For Generic Breast Cancer Drug
Gland Pharma has received approval from the US FDA to market a generic breast cancer drug, Eribulin Mesylate Injection.
Gland Pharma on Monday said it has received approval from the U.S. health regulator to market a generic medication used to treat breast cancer.
The company has received approval from the US Food and Drug Administration for Eribulin Mesylate Injection (0.5 mg/mL single dose vial), it said in a statement.
The product is expected to be the first generic approval in the market, and the company expects to launch this product in the near term through its marketing partner, it added.
According to IQVIA, the product has sales of around $92 million in the U.S. for 12 months ending in February 2024.
The company said it is co-developing several complex injectables, including the product, with Orbicular Pharmaceutical Technologies Pvt Ltd.
Shares of Gland Pharma on Monday ended 5.59% up at Rs 1,853.25 apiece on the BSE.
