Odomzo Approved for Locally Advanced Basal Cell Carcinoma (BCC)
July 24, 2015 – The U.S. Food and Drug Administration (FDA) approved Odomzo (sonidegib) manufactured by Novartis. Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. The recommended dose for Odomzo is 200mg, to be taken orally, once daily on an empty stomach, at least 1 hour before or 2 hours after a meal. Odomzo is expected to cost approximately $100,000 per year.
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
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.