NEWS 03 MAY 2019

NEWS FROM USA

NEW STRENGTH APPROVAL

 

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
2 May 2019	Dapagliflozin 5 mg/ Saxagliptin 5 mg	Astra Zeneca	QTERN	Link

Original NDA for Dapagliflozin/Saxagliptin was approved in Feb. 2017. It covered only single strength (Dapagliflozin 10 mg/ Saxagliptin 5 mg).

 

NDA APPROVAL (New combination)

Approval Date	Product Name	NDA Sponsor	Brand Name	Prescribing information
2 May 2019	Dapagliflozin/ Saxagliptin/Metformin ER tablets	Astra Zeneca	QTERNMET XR	Link

 

GENERIC PATENT LITIGATIONS

Cinacalcet (Cipla): The U.S. District Court of Delaware denied Amgen, Inc.'s request for preliminary injunction to stop Cipla's continued sale of its generic cinacalcet hydrochloride tablets 30mg, 60mg, 90mg in the USA.

-      Full Press release: Link

USFDA INSPECTIONS

Cadila healthcare provides update on USFDA inspection at company’s formulation manufacturing facility - Moraiya, Ahmedabad

-      The inspection was conducted between 22^nd April to 3^rd May 2019 by USFDA. It was concluded with 14 observations.

-      As per the company’s press release, there were no repeat observations or data integrity related observations.

-      Full Press release: Link

 

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