Sustol regulatory update

Heron (formerly A.P. Pharma) said it will delay the resubmission of an NDA to FDA for Sustol to prevent chemotherapy-induced nausea and vomiting (CINV) to 2Q14 from 1Q14. The company said it received a notice from the supplier of the syringes used for Sustol that the production of syringes will be delayed due to equipment failure. The syringes were scheduled to be used in the validation of the commercial manufacturing process for Sustol for the resubmission of the NDA. Heron hopes to launch Sustol in early 2015. The product is a long-acting formulation of granisetron, a serotonin (5-HT3) receptor antagonist, formulated using the company's Biochronomer drug delivery technology. ...