FDA Approves Finacea Foam
July 29, 2015 – The U.S. Food and Drug Administration (FDA) approved a new dosage form of Finacea (azelaic acid) 15% for the treatment of rosacea. Common in light skinned adults, rosacea is a chronic skin condition that causes redness and acne-like bumps on the face.
Similarly to Finacea Topical Gel, Finacea Foam is indicated for treating inflammatory bumps and pimples of mild to moderate rosacea. To use, a thin coating of Finacea Foam is applied twice daily to an already washed face (except eyes and lips), and allowed to dry. The regular 12-week treatment is only recommended for individuals aged 18 and above.
In September 2015, Bayer HealthCare plans will introduce Finacea Foam. It will be available in aerosol cans that contain 50Gm of Finacea. Opened cans of Finacea must be thrown away after 8 weeks whether or not they are empty.
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.