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TXT Fenwal Recalls Anticoagulant Due to Labeling Mishap [92 Words] [ Price : $7.95]
Fenwal recalls one lot of its Anticoagulant Citrate Phosphate Dextrose Solution, USP Blood-Pack Unit due to labeling mishap.
05/02/2013
 
 
TXT Supplier Wants OxyContin Impurity Limit Retained [176 Words] [ Price : $7.95]
Rhodes Technologies says FDA should not relax the current limit of 10 ppm on 14-hydroxycodeinone in oxycodone API.
05/02/2013
 
 
TXT Vicerex, Black Ant Supplements Recalled Due to ED Drugs [131 Words] [ Price : $7.95]
American Lifestyle recalls all lots of Vicerex and Black Ant capsules due to undeclared ingredients found in prescription erectile dysfunction drugs.
05/02/2013
 
 
TXT New Mobile App Regulatory Environment Needed: Expert [228 Words] [ Price : $7.95]
Speakers at a Politico health tech conference say more and stricter government regulation of mobile medical apps is needed.
05/02/2013
 
 
TXT Panel Votes Down Aveo’s Tivozanib [176 Words] [ Price : $7.95]
Aveo Oncology fails to gain the backing of FDA’s Oncologic Drugs Advisory Committee that reviewed an NDA for tivozanib.
05/02/2013
 
 
TXT Salix Wants Apriso Bioequivalence Criteria Imposed [338 Words] [ Price : $7.95]
Salix asks FDA not to approve any ANDA referencing its Apriso that doesn’t demonstrate bioequivalence through means requested by the company.
05/02/2013
 
 
TXT FDA Clears PlasmaJet for Removing Soft Tissue [83 Words] [ Price : $7.95]
FDA grants 510(k) clearance to Plasma Surgical for the PlasmaJet to remove soft tissue by vaporization.
05/01/2013
 
 
TXT FDA Releases Novartis Consumer Health Inspection Report [296 Words] [ Price : $7.95]
FDA releases an FDA-483 detailing inspection findings, including many repeat observations, from the latest inspection at the troubled Novartis Consumer Health drug manufacturing facility in Lincoln, NE.
05/01/2013
 
 
TXT FDA Releases New and Updated Safety Signal Reports [89 Words] [ Price : $7.95]
FDA releases new and updated quarterly reports on safety signals identified in drug products.
05/01/2013
 
 
TXT Forest, Almirall Plan NDA for COPD Drug in 4th Quarter [228 Words] [ Price : $7.95]
Forest Laboratories and Almirall plan an NDA submission in the fourth quarter for their investigational chronic obstructive pulmonary disease combination drug Pressair (aclidinium bromide and formoterol fumarate).
05/01/2013
 
 
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