Monday, March 3rd, 2008
Solvay Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved LUVOX® CR (fluvoxamine maleate) Extended-Release Capsules for the treatment of social anxiety disorder (SAD) and obsessive compulsive disorder (OCD) in adults.
In January 2007, Solvay Pharmaceuticals licensed the right to market LUVOX CR (fluvoxamine maleate) Extended-Release Capsules ...
Posted in Anxiety / Phobias | No Comments »
Tuesday, February 26th, 2008
The U.S. Food and Drug Administration announced that Brownwood Acres Foods Inc., Cherry Capital Services Inc. (doing business as Flavonoid Sciences) and two of their top executives have signed a consent decree that effectively prohibits the companies and their executives from manufacturing and distributing any products with claims in the ...
Posted in Nutrition / Diet | No Comments »
Monday, February 25th, 2008
AVANT Immunotherapeutics, Inc. (Nasdaq: AVAN) announced that Rotarix(R), an oral, two-dose rotavirus candidate vaccine to prevent rotavirus gastroenteritis in infants, received a favorable recommendation from the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC). AVANT licensed the technology for Rotarix® to GlaxoSmithKline in 1997 ...
Posted in GastroIntestinal | No Comments »
Saturday, February 23rd, 2008
Arbios Systems, Inc. (OTC Bulletin Board: ABOS) announced that the Company has received conditional approval from the U.S. Food and Drug Administration ("FDA") of an Investigational Device Exemption ("IDE") to begin the pivotal clinical trial for SEPET(TM), Arbios' extracorporeal (outside the body) artificial liver assist device for blood purification of ...
Posted in Liver Disease / Hepatitis | No Comments »
Saturday, February 23rd, 2008
It would "not only be unscientific but unethical" for FDA to reject Genentech's colon and lung cancer treatment Avastin for use as metastatic breast cancer treatment, a Wall Street Journal editorial says (Wall Street Journal, 2/21).
FDA is scheduled to decide Saturday whether to approve Avastin for treatment of metastatic breast ...
Posted in Breast Cancer | No Comments »
Friday, February 22nd, 2008
The U.S. Food and Drug Administration licensed a treatment for hemophilia A, a rare, hereditary blood-clotting disorder that affects approximately 15,000 individuals, almost exclusively males, in the United States.
The new treatment, called Xyntha Antihemophilic Factor (Recombinant) Plasma/Albumin Free, is a genetically engineered version of factor VIII, a protein essential for ...
Posted in Blood / Hematology | No Comments »
Friday, February 22nd, 2008
The Wall Street Journal on Wednesday examined House Energy and Commerce Oversight and Investigations Subcommittee Chair Bark Stupak's (D-Mich.) efforts to increase FDA oversight and improve the safety of prescription drugs. According to the Journal, Stupak is "at the center of an aggressive effort by congressional Democrats to spotlight what ...
Posted in Pharma Industry | No Comments »
Thursday, February 21st, 2008
FDA on Friday proposed new guidelines that would allow pharmaceutical and medical device companies to market their products for off-label uses, the New York Times reports (Harris, New York Times, 2/16). Currently, physicians can prescribe medications and medical devices for off-label uses, but companies cannot market their products for such ...
Posted in Pharma Industry | No Comments »
Wednesday, February 20th, 2008
FDA on Friday proposed new guidelines that would allow pharmaceutical and medical device companies to market their products for off-label uses, the New York Times reports (Harris, New York Times, 2/16). Currently, physicians can prescribe medications and medical devices for off-label uses, but companies cannot market their products for such ...
Posted in Pharma Industry | No Comments »
