NEWS 22 AUGUST 2018

 

NEWS FROM USA

NDA Approvals        

DRUG	COMPANY	Corresponding RLD	Press release if available
Stiripentol Capsule	Biocodex SA	N/A	Link
Stiripentol Powder	Biocodex SA	N/A	Link

 

ANDA Approvals     

DRUG	COMPANY	Corresponding RLD	Press release if available
Ranitidine Tablets	Granules India	Zantac (Sanofi)	Link
Hydrocortisone butyrate lotion, 1.0%	Lupin	Locoid	Link

 

Tentative Approvals           

DRUG	COMPANY	Corresponding RLD	Press release if available
Estradiol Valerate Tablets & Estradiol Valerate and Dienogest Tablets	Lupin	Natazia (Bayer)	Link

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Press Release
Clobetasol Propionate Cream	Lupin	Temovate (Fougera Pharmaceuticals)	Link

 

 

Other News from USA

Strides receives acceptance from USFDA for two key ANDAs under newly introduced Competitive Generic Therapy

 

News from JAPAN

Tagrisso approved in Japan for 1st-line treatment of EGFR-mutated non-small cell lung cancer

 

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