Article: Labopharm Receives Second Approvable Letter from FDA for Once-Daily Tramadol.

Article: Neurocrine Receives Approvable Letter for Indiplon ...
PR Newswire;  December 13, 2007 ;     700+ words ... ... where the 2006 Approvable Letter was discussed, the FDA requested that ... letter from the FDA stating that indiplon ... Approvable (2007 Approvable Letter). The 2007 Approvable ... previously raised by FDA in the 2006 Approvable Letter. The requirements ...

Article: Labopharm Falls 50 Percent On Second FDA Approvable ...
BIOWORLD Today;  June 4, 2007 ;     700+ words ... ... analgesic tramadol. The FDA sent Labopharm a second approvable letter on its new drug application ... 07. The first approvable letter from the FDA came in late September ... matters raised by the FDA in its first approvable letter. Our top priority ...

Article: FDA Wants More Trials Neurocrine Falls 49% On Second ...
BIOWORLD Today;  December 14, 2007 ;     700+ words ... ... Staff Writer The FDA delivered a second approvable letter for Neurocrine ... May 2006, the FDA delivered an unexpected approvable letter for the 5-mg ... meeting with the FDA to gain further clarity on the approvable letter.

Article: EPIX Pharmaceuticals Receives Second Approvable ...
Business Wire;  November 23, 2005 ;     700+ words ... ... Administration (FDA) has provided ... Company with an "approvable" letter related to the ... is the second approvable letter received by the Company from the FDA since the Company ... response to the FDA's approvable letter received in January ...

Article: FDA Issues Approvable Letter for Expanded ...
Business Wire;  December 11, 2001 ;     700+ words ... ... Administration (FDA) has issued ... Corporation an approvable letter relating to ... consider." An approvable letter usually represents ... product receives FDA clearance for ... information. The approvable letter was received from the FDA on November ...

Article: FDA "Approvable" Letter for Balsalazide ...
Medical Letter on the CDC & FDA;  April 11, 2000 ;     639 words ... ... receipt of an "approvable" letter from the U.S ... Administration (FDA) regarding the ... raised by the FDA in a prior approvable letter received by the ... raised by the FDA in the first approvable letter. We look forward ...

Article: Wyeth Receives Approvable Letter From FDA ...
PR Newswire;  January 23, 2007 ;     700+ words ... ... has received an approvable letter from the U ... Administration (FDA) for Pristiq ... According to the approvable letter, FDA approval of Pristiq ... Importantly, while the approvable letter requires some ... commitments, the FDA does not require ...