Lupin Limited has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Enzalutamide Tablets in strengths of 40 mg, 80 mg, 120 mg and 160 mg, expanding its oncology portfolio for the US market. The approval covers the 40 mg and 80 mg tablets as bioequivalent to Xtandi® tablets, the reference listed drug marketed by Astellas, for the indications specified in the approved prescribing information. In addition, Lupin has secured tentative approval for 120 mg and 160 mg tablet strengths, offering healthcare providers and patients additional dosing options that are not currently available with the branded product.
Tentative approval indicates that the product has met the FDA’s quality, safety and efficacy requirements for generic medicines but cannot be commercially launched in the United States until existing patent or regulatory exclusivity restrictions on the reference product expire or are otherwise resolved. The approval strengthens Lupin’s presence in the US generic pharmaceutical market and reflects the company’s continued focus on developing complex formulations that address evolving patient and physician needs. The introduction of additional tablet strengths is expected to simplify dosing regimens for certain patients while providing greater flexibility in treatment management once the product becomes eligible for commercial launch.
Enzalutamide is an androgen receptor inhibitor used in the treatment of specific forms of prostate cancer. The medicine is widely prescribed for patients with advanced stages of the disease and plays an important role in delaying disease progression and improving clinical outcomes. The latest regulatory milestone adds to Lupin’s growing portfolio of complex generic products and reinforces its strategy of expanding access to affordable therapies across key therapeutic segments, including oncology.
Headquartered in Mumbai, Lupin is among the world’s leading pharmaceutical companies, with products marketed in more than 100 countries. The company develops and manufactures branded and generic formulations, biotechnology products, active pharmaceutical ingredients and complex generic medicines, serving patients across a broad range of therapeutic areas.
Lupin has established a strong presence in both India and the United States, with leadership positions in respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system and women’s health therapies. Its global manufacturing network includes 15 production facilities and seven research and development centres, supported by a workforce of more than 24,000 employees.
