NEWS 29 NOV 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
29 Nov 2018	Amifampridine	Catalyst Pharma	Firdapse	Label
28 Nov 2018	Gilteritinib Tablets	Astellas	Xospata	Label

 

ANDA Approvals 

 

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
27 Nov 2018	Aminocaproic Acid Tablets	Sunny Pharmtech	Amicar (Clover Phama)	This product was mentioned in FDA’s off patent off exclusivity product with no generic list
29 Nov 2018	Lansoprazole orally disintegrating delayed release Tablets	Zydus	Prevacid (Takeda)	One

 

NEW GENERICS LAUNCHES IN US

DRUG	COMPANY	Corresponding RLD	Annual sales quoted in press release as per IQVIA	Press Release
Epinephrine Injection	Teva	Mylan (Epipen)	N/A	Link

                            

Tentative ANDA Approvals

 

Approval Date	Drug	Company
29 Nov 2018	Linagliptin Tablets	Zydus

 

 

NEWS FROM EUROPE

Final Approval from the EMA

Drug	Sponsor	Indication
Fingolimod (New patient population for MS; New strength 0.25 mg)	Novartis	Treatment of children and adolescents 10 to 17 years old with relapsing-remitting forms of multiple sclerosis (RRMS)
Doravirine / lamivudine / tenofovir disoproxil fumarate & Doravirine	Merck	Treatment of HIV-1

 

                                               

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