NEWS 08 AUG 2018

 

NEWS FROM USA

NDA Approvals        

DRUG	COMPANY	Corresponding RLD	Press release if available
Tigecycline Injectable	Amneal Pharms	N/A	Link
Mogamulizumab-Kpkc Injectable	Kyowa kirin	N/A	Link

 

ANDA Approvals     

DRUG	COMPANY	Corresponding RLD	Press release if available
Methadone Hydrochloride Tablets	Elite Labs	Dolophine Hydrochloride (West-Ward)
Tadalafil Tablets	Mylan Pharms	Adcirca (Eli Lilly )
Lidocaine Hydrochloride	B Braun Medical	Xylocaine (Fresenius Kabi)
Diclofenac Sodium Topical	Cipla	Voltaren (GSK)

 

 

Tentative Approvals           

DRUG	COMPANY	Corresponding RLD	Press release if available
Bimatoprost	Alembic	N/A

 

Other News from USA

FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs

 

Glenmark Pharmaceuticals Announces FDA Acceptance of the Company’s First New Drug Application for Ryaltris for Patients with Seasonal Allergic Rhinitis

 

Glenmark Pharmaceuticals’ partner Elite Pharmaceuticals receives US FDA approval for generic methadone hydrochloride tablet

 

 

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