Draxxin

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Withdrawal statement

On 2 December 2011, Pfizer Limited submitted an application for a type II variation for Draxxin to add the indication for Bordetella bronchiseptica to the existing list of claims for the treatment and prevention of swine respiratory disease (SRD), in accordance with Article 16 of Commission Regulation (EC) No. 1234/2008.

This claim was, inter alia, already applied for in 2008 within a previous variation application (EMEA/V/C/077/II/017). It was however not supported by the Committee for Medicinal Products for Veterinary Use (CVMP), because the data provided were considered inadequate.

In the current application, the applicant provided three new MIC studies on the respective organism isolated in Europe and North America to support the additionally claimed target pathogen. Furthermore, seven clinical field studies in pigs were submitted, performed in North America (n = 4) and Europe (n = 3). It is noted that the European studies have already been submitted to support the previous variation procedure (EMEA/V/C/077/II/017).

The efficacy of Draxxin at the recommended dosage in treatment and prevention of swine respiratory disease associated with Bordetella bronchiseptica was not reliably proven.

The CVMP considers on the basis of quality, safety and efficacy that this variation, accompanied by the submitted documentation, is not approvable since ‘major objections’ have been identified which preclude a recommendation for approval. The concerns were mainly in relation to efficacy.

On 11 May 2012, Pfizer Limited withdrew the application at day 91 of the procedure.

Name Language First published Last updated
Withdrawal assessment report for Draxxin: Extension of indication for Bordetella bronchiseptica (English only) 2012-07-04  

Key facts

Product details for Draxxin
NameDraxxin
INN or common name

tulathromycin

Active substancetulathromycin
Date of withdrawal11/05/2012
Company making the application

Zoetis Belgium SA

Withdrawal typePost-authorisation

All documents

Name Language First published Last updated
Withdrawal letter: Draxxin (English only) 2012-07-04  
Withdrawal assessment report for Draxxin: Extension of indication for Bordetella bronchiseptica (English only) 2012-07-04