Tentative FDA approval for chemotherapy generic

Genéricos/Novedades | Posted 13/11/2015 post-comment0 Post your comment

Aurobindo Pharma (Aurobindo) has received tentative US Food and Drug Administration (FDA) approval for chemotherapy generic palonosetron. The Indian generics maker received tentative FDA approval for its generic injectable intravenous palonosetron at a dosage of 0.25 mg/5 mL on 4 November 2015.

108 MD002320

The originator product Aloxi/Onicit/Paloxi (palonosetron) is manufactured by Helsinn Birex Pharmaceuticals and was approved by FDA on 25 July 2003.

Palonosetron is a second generation 5-HT3 antagonist (anti-emetic) used in the prevention and treatment of chemotherapy-induced nausea and vomiting. 5-HT3 antagonists work by reducing the activity of the vagus nerve, which is a nerve that activates the vomiting centre in the medulla oblongata. It is used for the control of delayed chemotherapy-induced nausea and vomiting and there are tentative data to suggest that it may be better than granisetron, an older 5-HT3 antagonist.

Aloxi/Onicit/Paloxi had worldwide sales in 2013 of around US$625 million, according to IMS data. The product is the market leader for chemotherapy-induced nausea and vomiting and has had compound sales since launch of US$4.1 billion, making it a top seller in more than 50 countries worldwide.

The patent on Aloxi expired in the US on 13 October 2015. Both Sandoz, the generics division of Novartis, and Teva Pharmaceutical Industries received approval of their generic versions of injectable intravenous palonosetron on 13 October 2015.

Two applications for generics of palonosetron are also under review by the European Medicines Agency [1].

Related article
US FDA approval for Hep B and osteoporosis generics

Reference
1.   GaBI Online - Generics and Biosimilars Initiative. Generics applications under review by EMA – August 2015 [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Nov 13]. Available from: www.gabionline.net/Generics/General/Generics-applications-under-review-by-EMA-August-2015

Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.

Copyright – Unless otherwise stated all contents of this website are © 2015 Pro PharmaCommunications International. All Rights Reserved.

Source: Helsinn, US FDA

comment icon Comments (0)
Post your comment
Most viewed articles
Sobre GaBI
INICIO/Sobre GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
INICIO/Directrices Posted 08/10/2010