Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older
This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States
The company does not expect this development to have any material impact on the current business operations
The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date
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Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas
Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis
Raichur site is the group’s largest API facility and part of a wider network of seven sites
The company expects to launch this product through its marketing partner in the near future
The IND application supports the next phase of development of SBO-154
The inspection has concluded with four observations
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