NEWS 08 OCT 2018

NEWS FROM USA

 

ANDA Approvals

           

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
03 Oct 2018	Pramipexole Dihydrochloride Tablets	Cspc Ouyi Pharm	Mirapex (Boehringer Ingelheim)	Fourteen
04 Oct 2018	Clobetasol Propionate Aerosol Foam	Taro Pharm	Olux (Mylan)	Two (Ingenus Pharms  & Perrigo Israel)
04 Oct 2018	Norepinephrine Bitartrate Injection	Mylan Labs	Levophed (Hospira)	Three
05 Oct 2018	Colesevelam Hydrochloride Tablets	Alkem Labs	Welchol (Daiichi Sankyo)	Three
05 Oct 2018	Colesevelam Hydrochloride Tablets	Dr Reddys Labs	Welchol (Daiichi Sankyo)	Three

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

 

Tentative ANDA Approvals           

Approval Date	Drug	Company
03 Oct 2018	Ingenol Mebutate	Perrigo UK Finco

 

USFDA FACILITY INSPECTIONS

Cadila Healthcare sweetens after EIR from USFDA

Vivimed Labs receives EIR from USFDA

 

Now, you can also follow us on twitter @pharmacaptions. If you have any query/suggestion then please write us at pharmacaption@gmail.com

                                                                                                                     

 

 

 

                                                                 `