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80 m and / or standard low-about 12 m), each at least EUR 6 engine, eligible under GVFG vehicle promotion regulations of the State of Baden-WE-rttemberg from 2014 and approvable according to traffic regulations and BOKraft.
In an approvable letter received on December 21, 2007, the FDA requested additional information concerning a CMC issue.
In the second approvable letter (dated May 30, 2007), the FDA stated that Labopharm has not demonstrated the efficacy of its once-daily formulation of tramadol because the statistical methods used to analyze data from Labopharm's clinical trials did not adequately address missing data relating to subjects who dropped out of the trials.
This approvable letter for DAYTRANA is positive news for Shire and our partner, Noven Pharmaceuticals," said Shire CEO Matthew Emmens.
B check, allow underwriters to take actions on approvable cases once inexorably condemned to "do time" in purgatorial pending files.
The companies say the approvable letter asks for additional data and analysis to address a number of remaining questions.
AUSTIN, Texas -- LDR, a privately held medical device company offering innovative spinal implants for both non-fusion and fusion applications, announced that it has received an Approvable Letter from the U.
An approvable letter indicates that the FDA has determined that the drug under review has the potential to be approved, but that certain issues need to be addressed or conditions must be met before it is fully approved.
Food and Drug Administration (FDA) indicating that the New Drug Application (NDA) for indiplon 5 mg and 10 mg capsules for the treatment of insomnia is approvable pending additional clinical and preclinical data.
23, 2004, letter concluded that Extina was not approvable because a clinical trial showed that the drug was no better than the placebo foam alone.
In October 2004, Advanced Magnetics submitted a complete response to an approvable letter received from the U.