Lupin Gets US FDA Approval For Generic Lenalidomide Capsules

Lupin Ltd. received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Lenalidomide Capsules within the range of 2.5 mg to 25 mg, the company said in an exchange filing.

Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma, in combination with dexamethasone. Multiple myeloma, as maintenance following autologous hematopoietic stem cell transplantation (auto-HSCT) and Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities.

This product will be manufactured at Lupin’s Pithampur facility in India. Lenalidomide Capsules, 2.5 mgh, 25 mg had an estimated annual sales of $7,511 million in the United States.

Lupin Ltd. is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets.

Lupin specialises in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients, the company said in the exchange filing.

The pharma company has a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. It also noted that it has 15 state-of-the-art manufacturing sites and seven research centers globally, along with a dedicated workforce of over 24,000 professionals.

Lupin's subsidiaries include Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

Earlier last year, the company received approval from the US health regulator to market its generic 'Minzoya' tablets used to prevent pregnancy.

The drug remains a generic equivalent of Balcoltra (Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ferrous Bisglycinate Tablets) 0.1 mg/0.02 mg and 36.5 mg, of Avion Pharmaceuticals LLC.

The manufacturing for Minzoya was also set to be done at Lupin's Pithampur facility in India.