Monday, September 6, 2010
1. Sepracor announced on June 30, 2010 that the second phase 3 trial for Omnaris HFA showed positive results. There are currently no nasal corticosteroids using aerosol, due to the Montreal Protocol. SanofiAventis received approved for Nasacort HFA several years ago, but declined to manufacture and market this product.
2. SkyePharma's combination asthma product, Flutiform, containing fluticasone and formoterol (sound familiar?), was essentially denied approval on June 24, 2010 from the F.D.A. because even more information was required. This could stop the company from continuing to seek approval in the U.S.3. Sepracor has not announced plans for a combination product made from 2 products it currently markets: ciclesonide + R-formoterol. Combination products are coming under intense scrutiny by the F.D.A. in the past few years due to their long-acting bronchodilating agents.