Aurobindo Pharma unit gets USFDA nod for prostate cancer drug

The drug maker announced that its wholly owned subsidiary, Eugia Pharma Specialties, received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Leuprolide Acetate injection, 14 mg/2.8 mL MDV (Kit).

Leuprolide Acetate for injection is indicated for the treatment used to treat the symptoms associated with advanced prostate cancer by way of Palliative treatment of advanced prostatic cancer.

The drug maker said the product will be a multiple-dose vials and it is therapeutically equivalent to the reference listed drug product (RLD), Lupron Injection,of AbbVie Endocrinology.

According to IQVIA, the approved product has an estimated market size of $83 million for the twelve months ending April 2022.

Aurobindo Pharma develops, manufactures and distributes generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients.

The company's consolidated net profit declined 28.1% to Rs 576.46 crore on a 3.3% fall in net sales to Rs 5,795.34 crore in Q4 FY22 over Q4 FY21.

Shares of Aurobindo Pharma were down 0.68% at Rs 519.25 on the BSE.

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