Drug Approval | April 10, 2024
Shivalik Rasayan’s API facility gets 7 observations from USFDA
These observations are procedural in nature and will be responded within the stipulated time
These observations are procedural in nature and will be responded within the stipulated time
The observations are procedural in nature and will be responded to within the stipulated time
The Product is expected to be the first generic approval on the market
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The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial
For the treatment of stenotic lesions of arteriovenous fistula in the haemodialysis management of chronic renal failure
Oscotec has successfully completed phase 2 study in patients with chronic ITP last year
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
The approved product has an estimated market size of US$ 44.5 million for the twelve months ending January 2024
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ II, India
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