| Open Document File Size: 2,10 MBShare Result on Facebook
Company Study Review / AEs / Aventis / Sanofi / Generic Name Propoxyphene Sponsor Xanodyne Pharmaceuticals Inc / Date SDN / / Country United States / / Event FDA Phase / Product Recall / Product Issues / / Facility ECG warehouse / / IndustryTerm oncology products / treatment of malaria / food effect studies / propoxyphene-containing products / / MedicalCondition systemic lupus erythematosus / thirddegree AV block / heart block / malaria / emetogenic cancer / rheumatoid arthritis / nausea / cirrhosis / GIST tumors / adult and pediatric cancer / complete heart block / pain / vomiting / torsade de pointes / acute pro-myelocytic leukemia / postoperative nausea / advanced renal cell cancer / atrial fibrillation / prostate cancer / First-Degree Atrioventricular block / advanced breast cancer / hepatic cirrhosis / / MedicalTreatment chemotherapy / / Organization FDA / Medicines and Healthcare Products Regulatory Agency / Advisory Committee / / Position cardiologist / representative / same evaluator / / Product INVIRASE / TIKOSYN / acetaminophen / cisplatin / Darvon / PLAQUENIL / ANZEMET / Darvocet-N / NORVIR / Propoxyphene hydrochloride / Darvon-N / NDA / Oral tablets / flecainide acetate / risperidone / KALETRA / RTV / CYP-3A4 / XP20C-101 / Saquinavir (SQV) / / ProvinceOrState Indiana / / Technology pharmacokinetics / AV / chemotherapy / 2.2 Protocol / /
SocialTag |
Interdisciplinary Review Team for QT Studies Consultation: Multiple Ascending Dose (MAD) Study Review IND