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17 Dec 2018

Is it always New molecule is first approved in USFDA, instead of the EU 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 of USFDA approval: 14th of December, 2018
USFDA approved indication: To treat chronic idiopathic constipation

This is the classic example of the new molecule approval takes place in EU before USFDA approval. Prucalopride was originally approved in EU for the symptomatic treatment of chronic constipation in women in whom laxatives fail to provide adequate relief. Subsequently, it has been approved by the European Commission for use in adults – that is, including male patients – for the same indication.

From strategic point of view, companies decide whether US or EU approval to proceed with or even sometime company decide on the both the submission to go ahead simultaneously. Few of the things which prompt companies to decide on which submission to start with are:

1. Competency of the companies in handling EU / USFDA approval process.
2. Companies HQs – Companies based in US, preferred to submit USFDA application first, similarly the case for European Companies.

3. Class of the molecule

4. Approval Time line of the EU / USFDA – Companies generally compare the regulatory bodies similar indication approval of same / similar class of the drugs.

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