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FDA approves Acton’s Aerospan flunisolide MDI

Acton Pharmaceuticals has announced plans to launch its Aerospan flunisolide HFA metered dose inhaler in early 2013 after having received FDA approval for the MDI. The product is approved for for the maintenance treatment of asthma in patients 6 years old and older, and the Aerospan device includes a built-in spacer. Acton acquired the Aerospan NDA from Forest Laboratories in 2009.

Acton CEO John Simon commented, “The FDA approval for Aerospan validates Acton’s commitment to bring forward important respiratory medicines for the millions of patients who suffer from asthma. We are very excited to have achieved this significant milestone, which is attributed to Acton’s sophisticated development team. Our ability to resolve complicated chemistry and manufacturing issues will now be leveraged to further develop our late-stage pipeline, including Nasacort HFA.”

The company is in the process of building inventory, considering strategic partnerships, and preparing for sales and marketing of the product, said Acton President Daniel Kreisler.

Read the Acton press release.

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published on September 20, 2012

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