CCNSB Capsules
Generic name:lomustine
Dosage form: capsule, gelatin coated
Drug class:Alkylating agents
Medically reviewed by Drugs.com. Last updated on Apr 21, 2022.
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NEXTSOURCE
Biotechnology
IMPORTANT DRUG INFORMATION
May 14, 2013
Dear Healthcare Professional:
RE: AVAILABILITY OF NEXTSOURCE CCNSB (LOMUSTINE) CAPSULES (10 mg and 40 mg)
CCNSB 10mg Lot # 3E02171
CCNSB 40mg Lot # 3E02191
Due to the current critical shortage of Lomustine capsules in the United States (US) market, NextSource Biotechnology is coordinating with the US Food and Drug Administration (FDA) to increase the availability of Lomustine Capsules, 10 mg and 40 mg. CCNSB (Lomustine Capsules) is the same product as the FDA approved CeeNu (Lomustine Capsules) with differences in distributor, trade name (unapproved), NDC number, and package size. This product is packaged in bottles of 5 capsules. A very limited initial supply of the NextSource product will contain the unapproved trade name, CCNSB, in addition to the required nonproprietary name, Lomustine Capsules. Subsequent shipments of the product will only contain the nonproprietary name, Lomustine Capsules.
The product is being supplied without the complete packaging configuration (i.e., with only the primary container label and a printed text version of the prescribing information without the secondary packaging). At this time, no other entity except NextSource is authorized by the FDA to distribute Lomustine Capsules in the U.S. Any sales of this product from any entity other than NextSource will be considered in violation of the Federal Food, Drug, and Cosmetic Act and is subject to enforcement by the FDA.
Please refer to the package insert for full prescribing information for CCNSB (Lomustine Capsules). Prescribing information can also be accessed by clicking the highlighted link below:
Nextsource Biotechnology – CCNSB Package Insert .
To report adverse events, please call NextSource Biotechnology at 855-672-2468, 24 hours a day/7 days a week. Adverse events that may be related to the use of this product may also be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, telephone, or fax:
- Online: www.fda.gov.medwatch/report.htm ..
