Pharmaceutical Business review

NextSource Biotechnology gains FDA approval for use of tradename Gleostine

The product name change from Lomustine (CCNU) to Gleostine represents the company’s strategic initiative to re-launch and re-brand its product pipeline of matured and innovative drugs.

The new Gleostine product labeling will be visible in the healthcare market by the fourth quarter of 2014. Lomustine is currently available through all payer organizations nationwide – including both commercial and government providers of prescription drug coverage.

Gleostine is a sole source FDA approved product, which is also accessible through NextSource CARES, NSB’s patient assistance program.

As a result of the company’s extensive market access efforts, the continued use of unregulated compounded products or any other unapproved versions of Gleostine, will continue to present an unnecessary risk to both healthcare providers and patients. NextSource Biotechnology is committed to providing the highest quality product with a consistent market supply.

"The re-branding of Gleostine," said Robert DiCrisci, President, CEO of NextSource Biotechnology, "is the first of many product launches to come. As this initiative continues, we will expand our product line to ensure consistent availability to patients with critical medical need."