Drug Approval | November 15, 2025
Zydus receives final approval from USFDA for Leuprolide Acetate injection
Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer
Leuprolide Acetate injection is indicated in the palliative treatment of advanced prostatic cancer
The observations are procedural in nature and will be responded to within the stipulated time
Dexlansoprazole delayed-release capsules are a proton pump inhibitor
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets
A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations
The Cranbury facility represents a strategic advancement of the company's operations in the Unted States
The NDA submission follows the successful completion of a pivotal Phase III global clinical trial
Lupin will address the observations and respond to the U.S. FDA within the stipulated timeframe
Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner
Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure
Subscribe To Our Newsletter & Stay Updated
