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22-May-2006 - Bristol-Myers Squibb Company announced that it has discontinued the development of muraglitazar, a dual alpha/gamma PPAR (peroxisome proliferator-activated receptor) agonist in development for type 2 diabetes and will focus its efforts on other priority portfolio projects. The U.S. Food and Drug ...
27-Mar-2006 - Akzo Nobel has received official acceptance from the Food and Drug Administration (FDA) in the United States regarding the self-affirmed GRAS (Generally Recognized as Safe) status of the company's Ferrazone® iron compound. Ferrazone, which is used as an iron fortificant in foods and beverages to ...
07-Feb-2006 - UCB announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion to approve marketing authorisation of Keppra® (levetiracetam) Concentrate (100 mg/mL) as an intravenous administration and for use as adjunctive ...
28-Dec-2005 - Makhteshim Agan Ltd. announced that its subsidiary LycoRed Natural Products Ltd. has received the FDA approval for the use of its product lycopene as a food coloring. The approval was granted on the basis of LycoRed's unique patent-protected production process, which gives it a significant ...
10-Nov-2005 - UCB announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to brivaracetam for the treatment of symptomatic myoclonus. Earlier this year, in August 2005, the European Commission granted orphan medicinal ...
08-Nov-2005 - PLIVA d.d. announced that PLIVA Inc., its US generics subsidiary, has received final approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Citalopram Hydrobromide Tablets 10 mg, 20 mg, and 40 mg. Citalopram Hydrobromide is the AB-rated ...
10-May-2004 - The Food and Drug Administration today announced that it will embark on a thorough scientific assessment of the health significance of very low levels of furan -- a chemical that is produced through the heating process - in certain foods. FDA has initiated this process through a notice on display ...
22-Nov-2001 - FDA today approved the first biologic treatment for the most serious forms of sepsis, a life-threatening illness caused by severe infection. The new treatment is a genetically engineered version of a naturally occurring human protein, Activated Protein C, which interferes with some of the body's ...
24-Sep-2001 - The Food and Drug Administration has licensed the first nucleic acid test (NAT) systems intended for screening of plasma donors. These test systems are expected to further ensure the safety of plasma-derived products by permitting earlier detection of HIV and HCV infections in donors. Although ...
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