NextSource Biotechnology announced that it has gained FDA approval for the use of tradename Gleostine (lomustine) as part of the company’s plan to re-launch the medication.

Lomustine is an alkylating agent that is indicated as a single agent in addition to other treatment modalities or in established combination therapy with other approved chemotherapeutic agents for the treatment of primary and metastatic brain tumors in patients who have already received appropriate surgical and/or radiotherapeutic procedures and for the treatment of Hodgkin’s disease in combination with other approved drugs in patients who relapse while being treated with primary therapy or who fail to respond to primary therapy.

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In 2013, Bristol-Myers Squibb discontinued production of CeeNu (lomustine) and NextSource Biotechnology took over as the sole distributor of lomustine in the United States.

Lomustine is available in 10mg, 40mg, and 100mg capsules. The new product labeling will be launched in late 2014.

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