Restylane Refyne and Restylane Defyne Dermal Fillers Approved
December 12, 2016 - The U.S. FDA approved Restylane® (Refyne) and Restylane® (Defyne) for the treatment of nasolabial folds or “laugh lines” in patients over 21 years of age, manufactured by Galderma. Restylane Refyne is approved to treat moderate to severe facial wrinkles and folds while Restylane Defyne is approved to treat moderate to severe, deep facial wrinkles and folds. These Restylane products are next-generation hyaluronic acid dermal fillers. Several other Restylane products are currently available on the market.
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 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.