Gleostine Approved with New Strength
January 6, 2016 – The U.S. Food and Drug Administration (FDA) approved Gleostine (lomustine) 5mg capsules, manufactured by NextSource Biotechnology. Gleostine is indicated for treating brain cancer as well as for second-line therapy in combination with other drugs for patients with Hodgkin’s disease who relapse or fail to respond to other treatments. Gleostine already comes in 10mg, 40mg and 100mg capsules. With dosing at 130mg per meter squared (m2) of body surface area, patients often need capsules in different strengths to get the exact dose they need. Gleostine is to be taken once every six weeks.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.