Enstilar Approved for the Treatment of Psoriasis
October 16, 2015 – The U.S. Food and Drug Administration approved Leo Pharmaceutical’s Enstilar (calcipotriene/betamethasone dipropionate) Foam, 0.005%/0.064%. This is a new combination topical treatment for plaque psoriasis and is indicated to be used once daily by patients 18 years of age and older for up to four weeks at a time. Also, patients must not apply more than 60g over any four day period and must avoid smoking or use of Enstilar around open flames due to the flammable propellant used in it.
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. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.