Drug Approval | July 22, 2024
Briefs: Zydus Lifesciences and Divi's Laboratories
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Zydus receives final approval from USFDA for its NDA Zituvimeta, extended-release tablets
Rusan’s API facility in Ankleshwar is GMP approved by other stringent international agencies as well
Susvimo is a unique therapeutic approach that provides continuous delivery of medicine to the eye through a refillable implant
Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the U.S. (IQVIA MAT May 2024)
The inspection closed with five observations which were more of procedural changes with none of these related to data integrity
The company will address these observations within the stipulated timeline
Selexipag is a prostacyclin receptor agonist indicated for the treatment of pulmonary arterial hypertension
The facility is a part of Lupin Manufacturing Solutions
The approved ANDA is therapeutically equivalent to the reference listed drug product
Sacubitril and Valsartan combination is used to treat chronic heart failure in adults
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