Lupin secures USFDA approval for Lenalidomide capsules in US market

has received USFDA approval for its Lenalidomide Capsules (2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg), a bioequivalent of Revlimid, used in the treatment of Multiple Myeloma in combination with dexamethasone and as maintenance therapy post-autologous stem cell transplant. The drug, which also addresses transfusion-dependent anaemia in certain myelodysplastic syndromes, represents a sizeable opportunity with estimated US annual sales of $7.5 billion. The capsules will be manufactured at Lupin’s Pithampur facility. Meanwhile, the company’s Nagpur injectable unit came under scrutiny, with the USFDA issuing six observations, which Lupin has committed to address within timelines. Disclaimer: This post is for informational purposes only and not a recommendation to buy or sell any securities. I, or my family, associates, or relatives, may have a financial interest in the securities mentioned.