Drug Approval | February 21, 2025
USFDA classifies Aurobindo Pharma Inc's warehouse as OAI
The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated
The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated
the inspection conducted from January 27 to January 31, 2025
Observations are largely around improvement of procedures and practices
The Alathur facility specializes in the production of Cephalosporin antibiotics
Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved
Vaccine helps protect against five common disease-causing serogroups of Neisseria meningitidis (A, B, C, W and Y)
Evrysdi is the only non-invasive disease-modifying SMA treatment and is approved in over 100 countries
Approval is based on positive data from the Phase 3 ECHELON-3 trial
Ipratropium Bromide Nasal Solution is indicated for the symptomatic relief of rhinorrhea associated with allergic and nonallergic perennial rhinitis
EMBLAVEOTM is the first and only monobactam/?-lactamase inhibitor combination antibiotic therapy approved by the USFDA
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