NEWS 20 DEC 2018

NEWS FROM USA

NDA Approvals        

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
18 Dec 2018	Rosuvastatin Capsule (505(b)2 against Crestor tablets)	Sun Pharma	Ezallor	Link

 

505(b)2 IN PIPELINE:

Liposomal Cisplatin (Oncology Venture): Oncology Venture receives positive feed-back from the FDA on approval pathway for LiPlaCis and DRP in the US

ANDA Approvals              

                            

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
14 Dec 2018	Heparin Sodium Injection	Nanjing King-Friend	Heparin Sodium (Fresenius Kabi)	Six
17 Dec 2018	Naloxone Hydrochloride Injection	Renaissance SSA	N/A	Twelve
17 Dec 2018	Norepinephrine Bitartrate Injection	Amneal Pharms	Levophed (Hospira)	Six
18 Dec 2018	Cyanocobalamin Injection	Vitruvias	Cyanocobalamin (Luitpold)	Five
18 Dec 2018	Cyanocobalamin Injection	Somerset	Cyanocobalamin (Luitpold)	Five

 

TENTATIVE ANDA APPROVALS

 

Approval Date	Drug	Company
17 Dec 2018	Sapropterin Dihydrochloride	Dr Reddys Labs
17 Dec 2018	Apixaban	Breckenridge

 

 

USFDA INSPECTIONS

Alembic Pharma announces successful USFDA Inspection at their API Facility (Panelav).

OTHER NEWS FROM THE USA

Vigabatrin (Catalyst/Par): Catalyst Pharmaceuticals Announces Definitive Agreement with Endo for Vigabatrin Tablets (At present Vigabatrin tablets are mentioned in FDA’s off patent off exclusivity list)

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