80 m and / or standard low-about 12 m, each for at least EUR 6 engine, eligible under GVFG vehicle promotion provisions of the State of Baden-WE-rttemberg from 2014 and approvable
according to traffic regulations and BOKraft.
In addition, the number of approvable
letters, which state what conditions must be met for a drug to be approved increased.
to the FDA approvable
letter for Once-A-Day LUVOX(R) CR (fluvoxamine maleate) Extended-Release Capsules.
TSX: DDS, NASDAQ: DDSS) today announced that it has received a second approvable
letter from the U.
Shire plc has received an approvable
letter from the U.
Clean" cases approvable
via "the system," typically, without underwriter intervention.
Vancouver, British Columbia, announced that its licensee Shire Pharmaceuticals Group plc, Basingstoke, UK, has received an approvable
letter from the FDA for Fosrenol as a treatment for high phosphate levels in the blood, which occur in patients undergoing dialysis as a result of chronic kidney failure.
Mobi-C is the first cervical disc to receive an approvable
letter for two-level use in the United States following a 600 patient concurrent IDE Clinical Trial for one and two-level cervical disc replacement
Food and Drug Administration (FDA) has issued an approvable
letter for Once-A-Day LUVOX(R) CR (fluvoxamine maleate) Extended-Release Capsules, for which Jazz Pharmaceuticals and Solvay Pharmaceuticals, Inc.
Although the company would not specify the FDA's reasons for deeming the drug not approvable
, the agency had requested that Novartis submit clinical data on the liver profile of the proposed 100-mg once-daily dose studied over 12 months of therapy.
In the July approvable
letter, the FDA stated that the drug's manufacturer, Wyeth Pharmaceuticals, would have to provide more data about the potential for serious adverse cardiovascular and hepatic effects associated with the use of the desvenlafaxine for this indication, according to the company.
This decision follows a number of meetings with the FDA since October 2004, when the Company received an Approvable
Letter from the FDA for Riquent.