Eugia Steriles gets 3 observations from USFDA for injectable facility
The observations are procedural in nature and will be responded to 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
For the first-line treatment of certain patients with metastatic non-small cell lung cancer
This is the fourth authorized indication in Europe for Reblozyl, a first-in-class treatment for patients with disease-related anemia
The average time of dilation lasts three to eight hours
First and only long-acting C5 complement inhibitor offers patients with AQP4 Ab+
Letermovir tablets, 240 mg and 480 mg had annual sales of USD 289.5 mn in the United States (IQVIA MAT Jan-24)
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
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