Alembic Pharmaceuticals (NSE:APLLTD, BOM:533573) has received tentative approval from the U.S. Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Larotrectinib Capsules in strengths 25 mg and 100 mg, according to a Thursday filing.
The product is a generic version of Vitrakvi Capsules of Bayer Healthcare Pharmaceuticals, the filing said. It is used for the treatment of certain solid tumors with a neurotrophic receptor tyrosine kinase gene fusion, where no satisfactory alternative treatment exists or the disease has progressed after prior therapy, the company said in the filing.
Alembic said that after obtaining final approval of this ANDA, it may be "eligible for 180 days of generic marketing exclusivity in the U.S."
The company added that the product has an estimated U.S. market size of about $91 million.