NEWS 25 JULY 2018

 

NEWS FROM USA

NDA Approvals

DRUG	COMPANY	LABEL
Ivosidenib tablets   Approval date: 20 july 2018	Agios pharmaceuticals	Prescribing Information
Elagolix sodium Tablet Approval date: 23 july 2018	Abbvie inc	Prescribing Information
Doxercalciferol Injection Approval date: 24 july 2018	Hospira	Prescribing Information

 

ANDA Approvals     

DRUG	COMPANY	Corresponding RLD	Press release if available
Hydrocortisone cream	Teligent	N/A
Sodium chloride injection	Fresenius kabi	Sodium chloride 0.45% in plastic container  (B Braun)
Nadolol tablets	Beximco	Corgard (US worldmeds)

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Press Release
Metformin hydrochloride ER tablets	Sun Pharma	Glumetza	Link

 

 

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