NEWS 21 SEP 2018

NEWS FROM USA

ANDA Approvals     

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
18 Sep 2018	Levonorgestrel Tablets	Apotex	Plan B One-Step	Twelve
19 Sep 2018	Tetracycline Hydrochloride Capsule	Amneal	Achromycin V (Heritage Pharma)	Two (Chartwell & Watson)
19 Sep 2018	Palonosetron Hydrochloride Injection	Sagent	Aloxi (Helsinn Hlthcare)	Eleven. (First Filier’s Patent Challenge Exclusivity Expired On 19 Sep. 2018
19 Sep 2018	Palonosetron Hydrochloride Injection	Qilu Pharm
19 Sep 2018	Palonosetron Hydrochloride Injection	Cipla
19 Sep 2018	Palonosetron Hydrochloride Injection	Mylan
19 Sep 2018	Palonosetron Hydrochloride Injection	Fresenius
19 Sep 2018	Palonosetron Hydrochloride Injection	Fresenius
19 Sep 2018	Palonosetron Hydrochloride Injection	Hospira
19 Sep 2018	Palonosetron Hydrochloride Injection	Virtus
19 Sep 2018	Aripiprazole Tablets	Mylan	Abilify (Otsuka)	Fourteen
19 Sep 2018	Dexmethylphenidate Hydrochloride Tablets	Cediprof	Focalin (Novartis)	Seven
21 Sep 2018	Busulfan Injection	Sandoz	Busulfex (Otsuka )	Seven

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

 

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Dalfampridine ER Tablets (Authorized Generic)	Mylan	Ampyra (Acorda)	$553	Link

 

NEWS FROM EUROPE

Sandoz receives positive CHMP opinion for proposed biosimilar pegfilgrastim

Novartis receives positive CHMP opinion for Gilenya for the treatment of children and adolescents with MS, marking a major medical advance for young MS patients in Europe

Novartis announces positive CHMP opinion for one-time gene therapy Luxturna to treat children and adults with rare inherited retinal disease

Sun Pharma Announces Receipt of European Commission Approval For ILUMETRI (tildrakizumab) By Almirall For Treatment Of Moderate-To-Severe Chronic Plaque Psoriasis

Valsartan: review of impurities extended to other sartan medicines

Mylan and Biocon Announce Positive CHMP Opinion for Fulphila, Biosimilar Pegfilgrastim

 

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