NEWS 24 JULY 2018

 

NEWS FROM USA

NDA Approvals

DRUG	COMPANY	LABEL
Tafenoquine tablets   NCE   Approval Date: 20 July 2018	GSK	Prescribing Information

New Biosimilar approval

DRUG	COMPANY	LABEL
Nivestym (Filgrastim-aafi)   Biosimilar to Neupogen	Hospira	Prescribing Information

 

ANDA Approvals     

DRUG	COMPANY	Corresponding RLD	Press release if available
Acetylcysteine injection	Zydus	Acetadote	Link
Sumatriptan; Naproxen tablets	Sun Pharma	Treximet
Gemcitabine injection	Sagent	Gemcitabine (Hospira)
Cetirizine HCl Allergy	Aurobindo	Cetirizine (Biopharma)
Cetirizine HCl hives relief	Aurobindo	Cetirizine (Biopharma)
Pyridostigmine Tablet	Invatech	Mestinon

 

Tentative ANDA Approvals

DRUG	COMPANY	Corresponding RLD
Oxcarbazepine	Actavis	N/A

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Press Release
Metformin ER tablets	Beximco pharma	Glocophage	Link
Potassium chloride oral solution	Amneal	Potassium chloride (Genus lifesciences)	Link

 

OTHER NEWS FROM USA

 

Aerie Pharmaceuticals Announces Early Notification of FDA Acceptance of NDA Submission for Roclatan™ (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005% with PDUFA Date Set for March 14, 2019

 

NEWS FROM EUROPE

NEW GENERICS LAUNCHES IN GERMANY

 

DRUG	COMPANY	Generic equivalent of	Press Release
Pemetrexed RTU	Stada	Alimta	Link

 

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