Kybella Approved to Reduce Under Chin Fat
April 29, 2015 – The U.S. Food and Drug Administration (FDA) approved Kybella (deoxycholic acid) injection manufactured by Kythera Biopharmaceuticals, Inc. Kybella is a cosmetic product indicated for improvement in the appearance of moderate to severe convexity or fullness associated with submental (under the chin) fat in adults.
Kybella is to be administered by trained physicians. Each treatment can include up to 50 subcutaneous injections of Kybella and may be administered as many as six times a month. During clinical trials however, some participants saw optimal results with as few as two treatments. Dermatologists, plastic surgeons and other prescribers who are expected to have high patient demand for the treatment will be trained first. Training will begin during the second quarter of 2015 and Kybella will only be distributed to those physicians who have successfully completed the training. The cost for Kybella is not yet available.
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.