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
_256_384.jpg)
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
Subscribe To Our Newsletter & Stay Updated
