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Norvir 100mg Tablet Filed for Registration with US FDA & EMEA

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Gus Cairns
Member
Posts: 257
Norvir 100mg Tablet Filed for Registration with US FDA & EMEA
Posted on: January 30 2009, 02:04 pm

Forwarded email from Paul Schaper of Abbott:

Dear Friends

I am pleased to announce that Abbott submitted applications seeking registration for a new tablet formulation of our protease inhibitor (PI) Norvir® (ritonavir) with U.S. and E.U. regulatory authorities at the end of 2008. This new, heat-stable formulation will not require refrigeration, which will make its use more convenient, particularly in developing countries where the majority of people with HIV live.

Abbott's development of the Norvir tablet is the result of the efforts of our scientists to address the needs of people living with HIV. Abbott scientists tested multiple formulations before developing and submitting the final formulation for regulatory consideration. The Norvir tablet was developed using Meltrex® technology, which is also used in Abbott's Kaletra® and Aluvia® tablets, a combination of lopinavir and ritonavir. Even with the use of Meltrex technology, ritonavir had unique formulation requirements to ensure stability and absorption.

Abbott first presented data from a pivotal study of bioavailability of the tablet, which compared the heat-stable formulation to the current Norvir soft gel capsule, at the XVII International AIDS conference in Mexico City (AIDS 2008) in August 2008.

Abbott intends to register the new Norvir tablet as broadly worldwide as lopinavir/ritonavir, the most widely registered PI worldwide, according to the World Health Organization.  Abbott’s Kaletra and Aluvia tablets are approved for sale, available (in countries where no regulatory approval is needed), or have been submitted for registration in 158 countries around the world.

If I can provide further information or address any questions you may have, please do not hesitate to contact me.

Sincerely,
Paul
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Simon Collins
Global Moderator
Posts: 651
Re: Norvir 100mg Tablet Filed for Registration with US FDA & EMEA
Reply #1 on: January 30 2009, 02:29 pm

It would be useful to know the expected timeline for review and a decision from each agency and whether this is being recognised as sufficiently important for it to be given fast-track status. Abbott have yet to get back to me with info on either point. Otherwise this is really PR.

Simon
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Ben Cromarty
Member
Posts: 451
Re: Norvir 100mg Tablet Filed for Registration with US FDA & EMEA
Reply #2 on: February 5 2009, 11:17 am

...it's about time! As Simon says, some timelines would be useful.
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