NEW DELHI– Indian pharmaceutical major Lupin has secured approval from the U.S. Food and Drug Administration (FDA) for its generic version of Lenalidomide capsules, a widely used treatment for certain blood cancers.
The FDA approved Lupin’s abbreviated new drug application for Lenalidomide in multiple strengths ranging from 2.5 mg to 25 mg. The drug is indicated for adult patients with multiple myeloma in combination with dexamethasone, including as maintenance therapy after stem cell transplantation. It is also approved for treating transfusion-dependent anemia in myelodysplastic syndromes linked to deletion 5q abnormalities.
Lupin’s generic is a substitute for Revlimid, developed by Bristol-Myers Squibb. The Mumbai-based company said the product will be manufactured at its Pithampur facility in Madhya Pradesh and will provide a cost-effective alternative for U.S. patients.
Revlimid is among the most lucrative cancer drugs on the market, with estimated annual sales of $7.5 billion in the United States, according to Lupin’s filing.
Lupin, which operates in more than 100 markets worldwide, has 15 manufacturing facilities and seven research centers, employing more than 24,000 people. Along with generics, the company also develops complex formulations, biotechnology products, and active pharmaceutical ingredients.
The FDA nod comes on the heels of Lupin’s approval for Minzoya, a generic contraceptive equivalent to Avion Pharmaceuticals’ Balcoltra. That product, too, will be produced at the company’s Pithampur site.
On Thursday, Lupin’s stock dipped marginally on the Bombay Stock Exchange, closing at Rs 2,030.50, down 0.03 percent. The shares are still up 3.17 percent over the past month. (Source: IANS)
