Hyderabad-based Natco Pharma Limited announced submission of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the US Food and Drug Administration (FDA) for the generic version of erdafitinib tablets 3 mg, 4 mg, and 5 mg strengths.
Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC). Erdafitinib tablets are marketed in the United States (US) by Janssen Biotech under brand Balversa.
Natco has been named as defendant in a lawsuit filed in the US district court of New Jersey by Janssen Pharmaceutica NV, Janssen Biotech Inc. and Otsuka Holdings Co.’s Astex Therapeutics Ltd.
Natco believes that the ANDA is possibly sole first-to-file based on its filing date and may be eligible for 180 days of marketing exclusivity at the time of launch
