Indian pharma major Lupin announced that the US Food and Drug Administration has approved its abbreviated new drug application for Lenalidomide capsules in strengths of 2.5 mg to 25 mg for cancer patients.
Lenalidomide has been approved for treatment of adult patients with multiple myeloma — a deadly blood cancer — when used with dexamethasone as maintenance therapy after autologous haematopoietic stem cell transplantation, the company said in an exchange filing.
It is also indicated for transfusion-dependent anaemia in low- or intermediate-1-risk myelodysplastic syndromes linked to a deletion 5q abnormality.
Lenalidomide capsules are a generic version of Revlimid capsules, developed by American multinational Bristol-Myers Squibb Company.
The product will be manufactured at Lupin’s Pithampur facility in Madhya Pradesh, the statement added.
Lupin announced that its generic product will provide a cost-effective alternative to Revlimid.
Lenalidomide capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg (RLD Revlimid) had estimated annual sales of $ 7,511 million in the US, the company said.
Lupin, headquartered in Mumbai, operates as a global pharmaceutical company in more than 100 markets and focuses on branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
The company has 15 manufacturing sites and seven research centres globally, with over 24,000 employees.
Lupin had recently also received the US administration’s approval for Minzoya, a generic contraceptive tablet.
The drug remains a generic equivalent of Balcoltra developed by US-based Avion Pharmaceuticals LLC. Minzoya will also be manufactured at Lupin’s Pithampur facility.
Meanwhile, Lupin’s shares on Thursday dipped marginally to ₹2,030.50, down ₹0.70, or 0.03 per cent, from the previous day’s close.
Over the past five trading days, the stock has been down ₹5.30, or 0.26 per cent. Over the past month, the pharma giant’s shares have gained ₹62.30, or 3.17 per cent.
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