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
The company had submitted a comprehensive Corrective and Preventive Action (CAPA) plan in September 2022
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals
The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products
The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets
The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin
SigTuple’s AI100 with Shonit is the premier solution for AI assisted digital pathology
The delegation's visit covered a wide range of topics
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