Synerx Pharma announces FDA submission of Isosulfan Blue injection ANDA
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Synerx Pharma, LLC has announced 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.
Lymphazurin has been in limited supply for a number of years, with shortages due to supply and manufacturing problems in 2001, 2002, 2006, 2007, and 2008.
Synerx Pharma believes the ANDA submission, which it has already submitted, qualifies for the FDA Office of Generic Drug’s GIVE (Generic Initiative for Value and Efficiency) program. This program seeks to provide an accelerated FDA review of generic products.
Indications and Usage: Lymphazurin 1% (isosulfan blue) upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. It is an adjunct to lymphography in: primary and secondary lymphedema of the extremities; chyluria, chylous ascites or chylothorax; lymph node involvement by primary or secondary neoplasm; lymph node response to therapeutic modalities.
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