Drug Approval | August 11, 2024
Zydus receives final approval from USFDA for Valbenazine Capsules
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
Valbenazine Capsules had annual sales of US $1,993.6 mn in the United States (IQVIA MAT June 2024)
Research & Development (R&D) investments for the quarter stood at Rs. 392.5 crore which is 6.3% of its revenues
Trazodone tablets are indicated for the treatment of major depressive disorder in adults
The sales of medicines and other items sold through Jan Aushadhi Kendras have increased from Rs. 7.29 crore in 2014 to Rs. 1,470 crore by July 2024
The EIR was issued post the last inspection of the facility conducted from May 6-10, 2024 which concluded with zero FDA 483 observations
The drugmaker's net profit slipped 26 per cent on-year to Rs 143.8 crore
Observes no adverse impact of non-nutritive sweetener (NNS) - sucralose on glycemic markers
Both departments will be equipped with specialized professionals and state-of-the-art facilities ensuring the highest standards of care
Being the first approved applicant, Lupin is eligible for 180 days of CGT exclusivity
The successful completion of the global Phase 3 trials paves the way to obtain marketing approval in the U.S. and EU
Subscribe To Our Newsletter & Stay Updated
