Gland Pharma gets USFDA nod

New Delhi: Gland Pharma on Monday said it has received approval from the US health regulator to market a generic medication used to treat breast cancer. The company has received approval from the US Food and Drug Administration (USFDA) 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 US 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 per cent up at Rs 1,853.25 apiece on the BSE.