FDA Submission Of Isosulfan Blue Injection ANDA

Main Category: Lymphology/Lymphedema
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 23 Dec 2008 - 2:00 PDT

email to a friend   printer friendly   opinions  

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.

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.

About Synerx Pharma, LLC

Synerx Pharma, LLC is a privately held corporation located in historic Bucks County Pennsylvania. Established in January 2004, the company develops and markets select pharmaceutical products aimed at meeting unmet market needs, particularly those involving some combination of barriers to entry. The company focuses on developing cost effective specialty generic pharmaceuticals and small brand products.

About Apicore, LLC

Apicore, LLC is a developer and manufacturer of Active Pharmaceutical Ingredients (APIs) according to current Good Manufacturing Practices (cGMPs). Based at an FDA inspected facility in Somerset, N.J., the company is committed to helping clients obtain timely approval for their ANDAs, NDAs and marketing authorizations by supplying APIs and technical support throughout the development and regulatory review process.

Lymphazurin™ is a trademark of United States Surgical, a division of Tyco Healthcare Group LP.

Synerx Pharma, LLC

• Additional
• References
• Citations