Drug Approval | April 13, 2024
USFDA completes inspection of Lupin's Dabhasa facility with no observations
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
The inspection was conducted from April 8 to April 12, 2024 and concluded with no observations
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly
The company will respond to the Warning Letter within the stipulated timelines
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
TriClip offers a remarkably safe, minimally invasive treatment option for patients in need of tricuspid valve repair but who are unable to withstand surgery
Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux
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