case study new drug approval Archives • NCK Pharma

Case Study: USFDA approval of Exeltis’s Slynd, an oral contraceptive tablet

Posted on10 Jun 2019

Tagscase study new drug approval, NDA, Slynd, usfda

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Exeltis USA, Inc. a division of the global pharmaceutical group Insud Pharma, announced that the US Food and Drug Administration (FDA) has...

Is it always New molecule is first approved in USFDA, instead of the EU approval?

Posted on17 Dec 2018

Tagscase study new drug approval

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Well, it’s not always true. Lets look into the recent example of the new molecule approval. Brand Name: Motegrity Molecule: prucalopride Date...

Amgen got USFDA Approval For Once-Monthly Cholesterol-lowering Evolocumab (Repatha) Device

Posted on12 Jul 2016

TagsAmgen, case study new drug approval, Evolocumab

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The US Food and Drug Administration (FDA) has approved the evolocumab (Repatha, Amgen) Pushtronex system, the first once-monthly delivery option for a...

Case Study: FDA approves Esbriet® (pirfenidone) to treat idiopathic pulmonary fibrosis

Posted on27 Oct 2014

Tagscase study new drug approval, Esbriet, FDA approves Esbriet® (pirfenidone) to treat idiopathic pulmonary fibrosis, pirfenidone

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The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF). Idiopathic pulmonary fibrosis is...