NEW 03 DEC 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
03 Dec 2018	Dexamethasone Ophthalmic Insert	Ocular Therapeutix	Dextenza	Link

 

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
03 Dec 2018	Ganirelix Acetate Injection	Sun Pharma	Ganirelix Acetate (Organon)	None
01 Dec 2018	Teriflunomide Tablets	Zydus	AUBAGIO (SANOFI)	Six
28 Nov 2018	Lansoprazole Orally Disintegrated DR Tablets	Mylan	PREVACID (Takeda)	Two (Teva, Zydus)
28 Nov 2018	Glycopyrrolate Injection	Aurobindo	None	Eight
29 Nov 2018	Sevelamer Carbonate Tablets	Wilshire	Renvela (Sanofi)	Six
29 Nov 2018	Dexmedetomidine Hydrochloride Injection (4 mcg base/ml)	Fresenius	Precedex (Hospira)	One (Baxter)
29 Nov 2018	Colchicine Capsule	Par Pharma	Mitigare (Hikma )	None
29 Nov 2018	Fluocinonide Topical Solution	Encube	Lidex (Cnty Line )	Eight

 

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Nystatin and Triamcinolone Acetonide Cream	Lupin	Nystatin and Triamcinolone Acetonide Cream (Taro Pharma)	$54.3 Million	Link

                            

OTHER NEWS FROM EUROPE

Biosimilar Pegfilgrastim Co-Developed by Biocon Receives Approval in EU

                                               

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