NEWS 14 FEB 2019

NEWS FROM USA

New Paragraph IV filing

DRUG	Dosage form	Corresponding RLD	Date of Submission	Type of Submission (Based on Date)
Polyethylene Glycol 3350, Sodium Sulfate, Sodium Chloride, Potassium Chloride, Sodium Ascorbate, Sodium Sulfate and Ascorbic Acid	For oral solution	Plenvu	6 Dec. 2018	Open First to File (Non NCE)

 

 

NDA Approvals                    

Approval Date	Drug	NDA Sponsor	Brand Name	Prescribing information
13 Feb. 2019	Triclabendazole tablets	Novartis	Egaten	Link

 

 

ANDA Approvals                                                  

Approval Date	Drug Product	ANDA Sponsor	Corresponding RLD	Number Of Other Approved Generics
11 Feb 2019	Ethinyl Estradiol; Ethynodiol Diacetate Tablets	Novast	N/A	Three
11 Feb 2019	Fenofibrate Tablets	Orit	N/A	Nine
11 Feb 2019	Dicyclomine Hydrochloride Injection	Custopharm	Bentyl (Allergan)	Eight
11 Feb 2019	Omeprazole DR Tablets	Apotex	Omeprazole (Dexcel)	Two (Dr Reddys, Sun Pharm)
11 Feb 2019	Triamcinolone Acetonide Cream	Strides	Triamcinolone Acetonide (Mylan)	Eight
13 Feb 2019	Triamterene And Hydrochlorothiazide Capsules	Zydus	Dyazide (GSK)	Four

           

 

Other news from the USA

Esketamine From Janssen Pharma: FDA Advisory Committee Recommends Approval of SPRAVATOTM (esketamine) Nasal Spray CIII for Adults with Treatment-Resistant Depression.

Golodirsen from Sarepta: Sarepta Announces FDA Acceptance of Golodirsen NDA for Patients with Duchenne Muscular Dystrophy Amenable to Skipping Exon 53

Pitolisant from Harmony Biosciences: Harmony Bioscience announced the USFDA has accepted for filing the NDA for pitolisant in the safety or effectiveness of the treatment of EDS and/or cataplexy in adult patients with narcolepsy when compared to existing treatments.

 

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