NEWS 21 NOV 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
16 Nov 2018	Rifamycin Dr Tablets	Cosmo Technologies	Aemcolo	Label
20 Nov 2018	Emapalumab-Lzsg Injection	Novimmune	Gamifant	Link

 

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
19 Nov 2018	Docosanol Cream	Actavis	Abreva (GSk)	None
20 Nov 2018	Vardenafil Hydrochloride ODT	Alembic	Staxyn (Bayer)	First approval for ODT
20 Nov 2018	Hydrocodone And Acetaminophen Tablets	Elite Pharma	Narco	Four

*Highlighted products are the 1^st generics approval for the corresponding RLD

 

Tentative ANDA Approvals

 

Approval Date	Drug	Company
16 Nov 2018	Deferasirox	Zydus
19 Nov 2018	Pregabalin	Rising

 

 

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Tetrabenazine Tablets	Lupin	Xenazine (Valeant Pharmaceuticals)	$153 Million	Link

                                                                                                                                               

OTHER NEWS FROM THE USA

Dr. Reddy's Laboratories announces favorable outcome in Buprenorphine and Naloxone (Suboxone) Sublingual Film patent litigation                                                                                                                 

 

                                                                            

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