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Denmark approves generic fluticasone/salmeterol DPI

Sandoz has received Danish marketing authorization for the AirFluSal Forspiro inhaler for the treatment of asthma and/or COPD in 50-250µg and 50-500µg versions. Sandoz acquired European rights to the product (formerly known as VR-315) from Vectura in 2006 and for the rest of the world except the US in 2011.

Sandoz Global Head Jeff George commented, “The first approval of AirFluSal Forspiro is a key element of our strategy to introduce differentiated generic medicines. This innovative new respiratory device underscores Novartis’s commitment to asthma and COPD patients and further strengthens Sandoz’ global leadership in differentiated products, which comprised 43 percent of our sales in 2012.”

Vectura CEO Chris Blackwell said, “The first approval of AirFluSal Forspiro is a milestone that de-risks our high value respiratory generic portfolio in Europe and the rest of the world. Once launched, we will begin to receive another new valuable royalty stream. The innovative new device is a further validation of our capabilities in respiratory drug development.”

The Forspiro multi-dose DPI won a Red Dot design award in 2011.

Read the Sandoz press release.

Read the Vectura press release.

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published on December 18, 2013

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