Drug Industry Daily

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The FDA appears to have a positive opinion of NPS Pharmaceuticals’ Gattex as a treatment for short bowel syndrome (SBS) patients, according to agency briefing documents.

The FDA has revised and clarified a final ICH question-and-answer guidance on the evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs.

The FDA wants more time to review Impax Laboratories’ Parkinson’s treatment Rytary and is pushing back its decision date to Jan. 21, 2013.

The FDA has issued an untitled letter to Genentech for educational aids aimed at healthcare professionals that overstate the efficacy and minimize the risks of its cancer drug Tarceva.

The FDA has approved a new indication for Celgene’s Abraxane in combo with carboplatin as a first-line treatment for locally advanced or metastatic non-small cell lung cancer (NSCLC) for patients who can’t undergo surgery or radiation therapy.