Yesterday, 2/3/10, FDA approved under 505(b)(2) Canadian-based Labopharm’s once-daily version of trazodone HCl for the treatment of depression (as of this writing, this approval is not posted on the FDA web site). The initial PDUFA date was July 18, 2009 but this was missed because FDA found issues when inspecting the API manufacturing facility – [...]
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You are currently browsing the Drug Kennel weblog archives for the day Thursday, February 4th, 2010.
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505(b)(2) Food Revealed
Published February 4th, 2010 in News Commentary and Uncategorized. 0 CommentsTalking about teaching old dogs new tricks! For over 40 years we’ve been spilling ketchup from those nasty packets. Today, Heinz revealed a vast improvement:
We can only wish all 505(b)(2) drug developments could impact so many lives!