NEWS 15 SEP 2018

 NEWS FROM USA

NDA Approvals        

Approval Date	Drug	Company	Brand Name	Press Release If Available
12 Sep 2018	Latanoprost Ophthalmic Emulsion	Sun	Xelpros	Label
13 Sep 2018	Moxetumomab Pasudotox-Tdfk Injection	Astrazeneca	Lumoxiti	Label
14 Sep 2018	Fremanezumab-Vfrm	Teva	Ajovy	Label

 

Tentative ANDA Approvals           

Approval Date	Drug	Company
14 Sep 2018	Alogliptin & Metformin hydrochloride tablets	Alembic

 

OTHER NEWS OF THE USA

 

FDA provides update on its ongoing investigation into valsartan products; and reports on the finding of an additional impurity identified in one firm’s already recalled products

 

USFDA INSPECTIONS

 

Lupin’s Nagpur facility inspection by US FDA concluded with no observation

 

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