Generic Eloxatin Suspension Makes At Risk Launches A Little Riskier
This article was originally published in The Pink Sheet Daily
Executive Summary
Teva and Hospira halt shipments of oxaliplatin after an appeals court temporarily stays FDA approval of their ANDAs.
You may also be interested in...
Industry/Agency Revolving Door Hits Spear In Nose, But Firm Relaunches ANDA
While Spear's generic fluorouracil is back on the market after a temporary restraining order expired June 18, the odyssey illustrates the risks to companies inherent in FDA relying on industry opinions during product review
Is FDA Less Confident In ANDAs? Stay On Efudex Generic May Set Precedent
FDA's decision to review its approval of a generic for Valeant's topical Efudex (fluorouracil) Cream 5% may create a precedent for future approvals of ANDAs for complex small molecule drugs and could set the stage for higher hurdles for eventual approvals of biogenerics
Cancer-Genomics Firm Quanticel Debuts With Close Ties To Celgene, And An Exit In Mind
Celgene will get exclusive use of Quanticel's single-cell genomic analysis to tweak its clinical pipeline, and it also has exclusive options to acquire the venture-backed start-up.