NextSource BioTechnology (NSB), an emerging specialty pharmaceutical manufacturing and marketing company focused on consolidating, re-branding and launching "Matured & Orphan Drugs," recently announced that its most recent product Lomustine (CCNU), formerly known as CeeNu by Bristol-Myers Squibb (BMS), which has officially been removed from the US Food & Drug Administration (FDA) Drug Shortage List. As a result of this new status, Lomustine (CCNU) is now readily available through NextSource's Nationwide Authorized Distribution supply chain.
Due to the successful product re-launch and market availability of Lomustine (CCNU), there is no longer a need for continued use of the unregulated compound equivalent product. Pharmacies currently compounding this product are doing so against the FDA Code of Federal Regulations.
Lomustine (CCNU) will continue to be distributed under the current name, while the pending FDA "Brand" name is under review for approval. Lomustine (CCNU) is the first of many "Matured Drugs" to be launched under the NextSource Biotechnology portfolio.
Robert DiCrisci, president, CEO of NextSource Biotechnology, said, "Our launch of Lomustine is an example of the NextSource commitment to work proactively with the FDA in an effort to prevent the discontinuation of existing and future drugs that are vital in the application of a well balanced treatment plan of traditional proven therapies and New therapy options that healthcare providers and patients in the hospital settings require under the new healthcare guidelines."
Lomustine (CCNU) is an oral chemotherapy medication that is used to treat primary and metastatic brain cancer. Lomustine belongs to a class of drugs known as nitrosourea anti-tumour alkylating agent. Unlike the more common nitrogen mustard alkylating agents, Lomustine (CCNU) crosses the blood-brain barrier quite effectively due to its high lipid solubility and the relative lack of ion-ization at physiological pH and is used in the treatment of both primary and metastatic brain tumours in patients. It works by bonding with DNA of rapidly dividing cells causing breakage of the DNA strands and eventually, the death of the cancer cell.
CordenPharma is an expert Contract Manufacturing partner helping leading pharmaceutical and biotechnology companies link their requirements for product success with their patients' healthier lives. CordenPharma has subsequently been the long-term manufacturing partner of the Lomustine product for both NextSource Biotechnology and Bristol Myers Squibb (CeeNu).
CordenPharma provides specialized technologies that are ideal for the development and manufacturing of oral, sterile, highly potent and antibiotic pharmaceutical Drug Products, their Active Pharmaceutical Ingredients, and associated Global Supply Chain and Packaging Services.