Pharma Industrial India Magazine - July - August 2024

Natco Pharma Submits ANDA for Generic Version of TABRECTA Luye Pharma Gets US FDA Approval of ERZOFRI Extended- Release Injectable Suspension Natco Pharma has submitted an Abbreviated New Drug Ap- plication (ANDA) containing a paragraph IV certification with the US Food and Drug Administration (FDA) for the generic version of TABRECTA (Capmatinib hydrochloride) Eq 150mg base and Eq 200 mg base tablets. TABRECTA is the brand of Novartis. Natco claims to be the first company to have filed a substantially complete ANDA containing a paragraph IV certification for this product and expects to be eligible for 180 days of sole marketing exclu- sivity at the time of the potential launch of the product under certain circumstances. TABRECTA has recorded sales of USD 126 million in the US market for the year 2023. Capmatinib hydrochloride is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NS- CLC) with a specific type of mutation. Luye Pharma Group has announced that the US Food and Drug Administration (FDA) has approved the company’s ER- ZOFRI (paliperidone palmitate) extended-release injectable suspension, for treating schizophrenia in adults and for treat- ing schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. Both schizophrenia and schizoaffective disorder are severe, chronic psychiatric disorders characterized by recurring re- lapses. Antipsychotic medications play an important role in treating and controlling symptoms of schizophrenia and schi- zoaffective disorder, but patient adherence to antipsychotics is generally poor. Using long-acting injectable (LAI) antipsychotics is effective in improving patient adherence, as they can reduce the dos- ing frequency and can also reduce the risk of patients not adhering to their dosing regimen without the knowledge of their healthcare providers. ERZOFRI, administered once a month, is the first patented paliperidone palmitate long-acting injection developed in Chi- na to get approved in the U.S. The product was granted a US patent (Patent No.11,666,573) in 2023, which will expire in 2039. ERZOFRI is approved as a new drug under the 505(b) (2) pathway in the U.S. According to publicly available information, the sales of pali- peridone palmitate LAIs were USD 2.897 billion across the US in 2023. ERZOFRI will provide patients with a new treatment option after its launch. FDA APPROVAL PHARMA INDUSTRIALINDIA · JUL-AUG 24 28