1 SC injection for 5 days of therapy; Phase III trial achieved mixed results 10/08; FDA accepts NDA 7/09 with PDUFA date of 3/18/10; FDA rejects drug 3/10, citing manufacturing deficiencies; though no new clinical efficacy studies needed, 2 bioavailability and metabolism studies are needed, in addition to a QT interval study (3/10)n
Brand N/A Generic granisetron (APF530)
Company name AP Pharma Product type Non-speciality
Therapeutic category Gastrointestinal Key uses Chemotherapy-induced nausea and vomiting
Other Uses N/A Drug Class 5HT3-antagonist
Dosage From SC Expected Approval 2011-Q4
FDA Filing 7/09 Last Update date April 02,2010
Link to pipeline report
Link to news release
Link to news article
Link to clinicaltrials.gov