March 20, 2017 – The U.S. FDA approved Juvéderm Vollure™ XC (hyaluronic acid), manufactured by Allergan. Juvéderm Vollure™ XC is the latest in Allergan’s line of dermal filler products and it is approved to smooth facial wrinkles, such as nasolabial folds (also called laugh lines) for patients over 21 years old. Vollure XC uses a proprietary technology that mixes different types of hyaluronic acids. The resulting gel is injected directly into the affected areas by a healthcare professional trained in its use. In studies, Vollure XC’s smoothing effects lasted up to 18 months for some patients. The Juvéderm division of Allergan plans an April launch to plastic surgeons, cosmetic surgeons, and other physicians. Full prescribing information has not yet been released.
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 U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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 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.