Please login to the form below

Not currently logged in
Email:
Password:

Par Pharma nausea drug approved

Strativa Pharmaceuticals, a division of Par Pharmaceutical Companies, has received US approval for its nausea-prevention drug Zuplenz

Strativa Pharmaceuticals, a division of Par Pharmaceutical Companies, has received US Food and Drug Administration (FDA) approval for its nausea-prevention drug Zuplenz (ondansetron). The drug is the first oral soluble film to be approved in the US as a prescription product.

The product is formulated so that it can be taken with or without water, and under fed or fasting conditions. The film, which dissolves on the tongue, is designed for ease of use by patients who have trouble swallowing or whose nausea and vomiting is worsened by drinking water.

Zuplenz is indicated for the prevention of post-operative, highly and moderately emetogenic cancer chemotherapy-induced, and radiotherapy-induced nausea and vomiting. The product is a new formulation of ondansetron, the active ingredient in GlaxoSmithKline's (GSK) Zofran ODT, an orally disintegrating tablet.

The approval was based on clinical bioequivalence data showing that Zuplenz is comparable to Zofran ODT, an orally dissolving tablet that can also be taken without water.

Zuplenz is formulated using MonoSol Rx's PharmFilm technology. Strativa and MonoSol Rx entered into an exclusive licensing agreement in 2008 for Zuplenz oral soluble film. The FDA approval has triggered $6m in milestone payments to MonoSol Rx under that deal.

The product is expected to be available in retail pharmacies in the third quarter of this year.

7th July 2010

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Accession

Accession was a born from a passion and a vision. A passion to harness the power of market access to...

Latest intelligence

PM Society Digital Awards – the power of together
Our chief executive, Emma Statham, writes about the value of awards and the power of together....
Seduction_feature_image_thumb.jpg
Seduce anyone in four simple steps
You know the health of the global economy is dependent on our ability to seduce one another – don’t you? And you know that we need to be able to...
What Would Jeremy Do? : Assessing the impact of a Corbyn-led Labour government
GK Strategy are delighted to announce the launch our latest briefing paper entitled ‘What Would Jeremy Do? Assessing the impact of a Corbyn-led Labour government’....

Infographics