ImClone Systems And Bristol-Myers Squibb Announce Revisions To ERBITUX(R) (cetuximab) U.S. Product Labeling For Metastatic Colorectal Cancer
ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company (NYSE: LLY), and Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved revisions to the U.S. prescribing information for ERBITUX® (cetuximab) concerning the treatment of patients with epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer (mCRC). The labeling revisions include a modification to the indication, which now includes a statement that retrospective subset analyses of metastatic or advanced colorectal cancer trials have not shown a treatment benefit for ERBITUX in patients whose tumors had K-ras mutations in codon 12 or 13 and that the use of ERBITUX is not recommended for the treatment of colorectal cancer with these mutations. Revisions concerning the use of ERBITUX in colorectal cancer tumors with K-ras mutations were also made to the clinical studies and clinical pharmacology sections of the product"s prescribing information.
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No Change In Pharmacokinetics Of ADHD Medication VYVANSE CII When Coadministered With Prilosec
or about 4.4 million children aged 4 to 17 years, have been diagnosed with ADHD at some point in their lives, according to the US Centers for Disease Control and Prevention (CDC). The disorder is also estimated to affect 4.4 percent of US adults aged 18-44 based on results from the National Comorbidity Survey Replication. When this percentage is extrapolated to the full US population aged 18 and over, approximately 9.8 million adults are believed to have ADHD. ADHD is a psychiatric behavioral disorder that manifests as a persistent pattern of inattention and/or hyperactivity-impulsivity that is more frequent and severe than is typically observed in individuals at a comparable level of development. The specific etiology of ADHD is unknown and there is no single diagnostic test for this syndrome. Adequate diagnosis requires the use of medical and special psychological, educational and social res, utilizing diagnostic criteria such as Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) or International Classification of Diseases 10 (ICD-10). Although there is no "cure" for ADHD, there are accepted treatments that specifically target its symptoms. Standard treatments include educational approaches, psychological, or behavioral modification, and medication. Mindy Huber Porter NovelliPages: 1 [2]