Drug Approval | October 09, 2023
Sun Pharma gets USFDA filing acceptance of new drug application for Deuruxolitinib
The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials
The NDA filing for deuruxolitinib with the U.S. FDA is based on two pivotal Phase III trials
LEO Pharma is developing delgocitinib cream for the treatment of moderate to severe chronic hand eczema, a hard-to-treat disease where there is a high unmet medical need for treatment
Zurletrectinib was developed to treat advanced or metastatic solid tumors harboring NTRK fusion genes
Erdafitinib is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma
Rare childhood cancer subtype, Ph+ ALL, is found in 3-4% of pediatric cases and 25% of adult cases
The company is already marketing the 4 mg and 10 mg strengths
The product will be produced at the Eugia Pharma Specialities, Unit-I, Medchal, Malkajgiri District, Telangana, India
Olverembatinib is the first and only third-generation BCR-ABL inhibitor approved in China for the treatment of adult patients with tyrosine kinase inhibitors
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
Tofacitinib Tablets, 5 mg and 10 mg had annual sales of US $900 million in the United States (IQVIA MAT December 2022)
Subscribe To Our Newsletter & Stay Updated
