Drug Approval | September 17, 2025
FDA approves Lupin’s Lenalidomide capsules
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
Lenalidomide Capsules are indicated for the treatment of adult patients with Multiple myeloma
Zydus will work closely with the USFDA to address and resolve the observations in an expeditious manner
This is Lupin's first product using proprietary Nanomi's technology and has a 180-day CGT exclusivity
Milrinone is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure
At the end of the current inspection, a 'Form 483' was issued with 5 observations which are procedural in nature and no data integrity issues were reported
The sudden subsequent decision to suspend IXCHIQ is based on updated VAERS data
The US generic market is crucial for Indian pharma, contributing about 35% to its total revenue, around US$ 10.7 billion
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VASOSTRICT Injection 40 Units per 100 mL and 20 Units per 100 mL of PH Health Limited
The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp
The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA
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