NEWS 06 SEP 2018

 NEWS FROM USA

NDA Approvals        

APPROVAL DATE	DRUG	COMPANY	Brand Name	Press release if available
05 Sep 2018	Riluzole Suspension	Italfarmaco	Tiglutik	Label

 

ANDA Approvals     

DRUG (Approval date)	ANDA sponsor	Corresponding RLD	Number of other approved generics
Bexarotene Tablets (4 Sep. 2018)	Amneal	Targretin	Three (Upsher smith, bion pharma & Amerigen)

 

Tentative ANDA Approvals           

APPROVAL DATE	DRUG	COMPANY
31 Aug 2018	Deferasirox	Bionpharma

 

OTHER NEWS FROM THE USA

 

Aurobindo Pharma acquires dermatology and oral solids business from Sandoz \

 

NEWS FROM EUROPE

European Commission approves Novartis combination therapy Tafinlar + Mekinist for adjuvant treatment of BRAF V600 mutation-positive melanoma

 

 

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