Drug Approval | November 20, 2024
Lupin receives USFDA approval for mixed salts of a single-entity amphetamine ER capsules
The product will be manufactured at Lupin’s Somerset facility in the US
The product will be manufactured at Lupin’s Somerset facility in the US
This product will be manufactured at Lupin’s Nagpur facility in India
Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad
Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Approval is based on Phase III INAVO120 results, showing the Itovebi (inavolisib)-based regimen more than doubled progression-free survival compared with palbociclib and fulvestrant alone in the first-line setting
Mylan and Novo Nordisk reach settlement of US patent litigation related to Ozempic
Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad
Gilead Sciences first launched Lenacapavir under the brand name Sunlenca in the United States and Europe markets in the year 2022
The observations are of procedural in nature and will be responded to within the stipulated time
HSGP is engaged closely with the USFDA and is committed to address the OAI observations through planned remediation measures
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