NEWS 30 AUG 2018

 

NEWS FROM USA

NDA Approvals        

DRUG	COMPANY	Brand Name	Press release if available
Eravacycline Injection	Tetraphase Pharms Inc	Xerava	Link
Doravirine Tablets	Merck	Pifeltro	Link
Doravirine; Lamivudine; Tenofovir Disoproxil Fumarate Tablets	Merck	Delstrigo	Link

 

ANDA Approvals     

DRUG	COMPANY	Corresponding RLD	Press release if available
Gabapentin Tablets	Lupin	Neurontin (Pfizer)	Link
Docetaxel Injection	Cipla	Docetaxel (Hospira)
Ketorolac Tromethamine Tablets	Cycle Pharma	N/A	Link
Gemfibrozil Tablets	Zydus	LOPID (Pfizer)	Link
Aripiprazole Orally Disintegrating Tablets	Zydus	ABILIFY DISCMELT (BMS)	Link

 

 

Other news for USA

 

USFDA Accepts Bristol-Myers Squibb’s Application for Sprycel (dasatinib) in Pediatric Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

 

NEWS FROM EUROPE

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

                  

 

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