New Botulinum Toxin Granted FDA Approval This Week

Merz Pharmaceuticals announced yesterday that FDA approval was granted for XEOMIN, a drug containing botulinum toxin.  The new drug is indicated for the treatment of cervical dystonia and blepharospasm.  Along with the relatively new Dysport and ubiquitous Botox®, Xeomin is the 3rd product of this kind to receive clearance in the U.S.

Two clinical trials were cited during the approval process, along with studies that compared XEOMIN to Botox®.  According to a study cited in the Journal of Neurological Sciences, [XEOMIN] showed “non-inferiority” to Botox® when used in equivalent doses for the treatment of blepharospasm.

The difference between XEOMIN and its competitors, according to the manufacturer Merz Pharmaceutical, is that “XEOMIN does not require refrigeration prior to reconstitution. “  The company says this could “simplify product distribution and storage, and help ensure product integrity at the time of injection.”

Merz is also acquiring Bioform Medical, a California company that manufactures Radiesse dermal filler.  The German company seems poised to create a significant presence in the U.S. aesthetics market.  When the acquisition of Bioform Medical is complete, the company will be rebranded “Merz Aesthetics.”

Tags: ,

Comments are closed.

Call us at or contact us online to schedule your consultation today.