NEWS 06 OCT 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
05 Oct 2018	Inotersen Injection	Ionis Pharms	Tegsedi	Label
05 Oct 2018	Elapegademase-Lvlr Injection	Leadiant Biosci	Revcovi	Label

 

 

ANDA Approvals

           

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
01 Oct 2018	Nitric Oxide Inhalation	Praxair Distribution	Inomax (Mallinckrodt Hosp)	None
03 Oct 2018	Exemestane Tablets	Zydus	Aromasin (Pharmacia And Upjohn)	Five
03 Oct 2018	Entacapone Tablets	Sunshine	Comtan (Orion Pharma)	Five
03 Oct 2018	Methylphenidate Hydrochloride Solution	Wes Pharma	Methylin (Specgx LLC)	Four
03 Oct 2018	Prazosin Hydrochloride Capsule	Novitium Pharma	Minipress (Pfizer)	Three
05 Oct 2018	Roflumilast Tablets	Breckenridge	Daliresp (AstraZeneca )	One (Torrent)

*For more details on ANDA approvals click on the Drug Product Name           

*Highlighted product indicates First generics approval for corresponding RLD

 

Tentative ANDA Approvals           

Approval Date	Drug	Company
28 Sep 2018	Minocycline Hydrochloride	Aurobindo
03 Oct 2018	Roflumilast	Micro Labs
03 Oct 2018	Ropivacaine Hydrochloride	Gland Pharma

 

NEW GENERICS LAUNCHES IN US

 

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Potassium Chloride Oral Solution	Lupin	Potassium Chloride (Genus Lifesciences)	$ 184.95 Mn	Link
Candesartan Hydrochlorothiazide Tablets (Authorized Generics)	Ani Pharma	HCT (Atacand)	$20 Mn	Link

                  

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