Category Archives: Approvable Letters

Approvable Letter Update

By my accounting, the FDA has just issued its fourth approvable letter so far in 2008.  Compare that to 2007 when by this date, the agency had issued a whopping 12 approvable letters.  And, according to an article carried on … Continue reading

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FDA Issues Another Approvable Letter

This time, the letter was directed to Astellas, and it isn’t the first one. According to an Astellas press release that was issued today, the company stated that it received an approvable letter for its NDA for FK 506 Modified … Continue reading

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Approvable Letter for MRSA Treatment

Basilea Pharmaceutica announced today that the FDA has issued an approvable letter for its first-in-class anti-MRSA agent cephalosporin for which company sought an indication to treat skin infections and diabetic foot infections. According to the company, prior to approval the … Continue reading

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Approvable Letter – Listing for 2007

I finally did it!  I have updated the listing of Approvable Letters that is housed in the left column of the blog under Resources by Me.  I now have all of the approvable letters listed that I have seen occur.  … Continue reading

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Impact of Approvable Letters 2007 – Part 2

Yesterday I posted about the impact of approvable letters and began by saying I have not yet been able to compare this year to other years, but my gut told me that it was a higher rate of approvables than … Continue reading

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