• Home Alimera receives FDA CRL for ILUVIEN NDA pSivida Corp.

Alimera receives FDA CRL for ILUVIEN NDA pSivida Corp.

Related StoriesInnovation in anaesthesia: an interview with Matti Lehtonen, GE HealthcareLiposomal sizing and the Coulter theory: an interview with Professor Melvin E. KlegermanExpanded use for IntelliCap with further CE Mark for aspiration of fluidsThe NDA seeks approval to advertise ILUVIEN , an investigational, sustained drug delivery program that releases sub-microgram levels of fluocinolone acetonide for the treatment of DME. On June 29 The ILUVIEN NDA was submitted to the FDA, 2010 with safety and efficacy data through month 24 of the FAME Study. The FDA granted the NDA Priority Review position on August 30, 2010.Overall, 122 patients presented with metastatic disease seeing that the original disease manifestation , whereas the placebo dose was low in 3 of 172 patients . The main reason for study-treatment discontinuation was disease progression, happening in 85 individuals receiving palbociclib and 3 patients receiving placebo.). Neutropenia occurred in 78.5 percent versus 4.1 percent, anemia in 26.1 percent versus 9.9 percent, and thrombocytopenia in 19.4 percent versus 0 percent. Grade 3 or 4 4 neutropenia happened in 62.2 percent versus 0.6 percent, anemia in 2.6 percent versus 1.7 percent, and thrombocytopenia in 2.3 percent versus 0 percent.