Synerx Pharma Release: FDA Submission of Isosulfan Blue Injection ANDA
12/16/2008 11:29:47 AM
NEWTOWN, Pa.--(BUSINESS WIRE)--Synerx Pharma, LLC announces the submission to the FDA of Isosulfan Blue Injection (generic equivalent to Lymphazurin™, Covidien (formerly US Surgical)). This ANDA submission is the culmination of a four year joint effort by Synerx Pharma, LLC and its exclusive raw material supplier Apicore, LLC. According to Synerx Pharma and Apicore, the active ingredient is extremely difficult to synthesize. Synerx Pharma stated that this product fits nicely into their Company’s strategic direction; it is a difficult to produce product, serves a critical medical need, and represents an unmet market need.