Drug Approval | April 10, 2024
Strides receives USFDA approval for Fluoxetine Tabs 10 mg and 20 mg
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly
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
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)
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