Please login to the form below

Not currently logged in
Email:
Password:

Xeomin receives FDA approval

The FDA has approved Merz Pharmaceuticals' botulinum toxin type A for the treatment of adults with cervical dystonia and blepharospasm

The US Food and Drug Administration (FDA) has approved Merz Pharmaceutical's Xeomin (incobotulinumtoxinA), a botulinum toxin type A for the treatment of adults with cervical dystonia or blepharospasm.

Approval was based on the results of two pivotal US clinical trials involving adult patients diagnosed with either cervical dystonia or blepharospasm. Active comparator studies conducted in Europe, which evaluated Xeomin versus Botox (onabotulinumtoxinA), were also included in the data submitted in support of the registration filing in these conditions.

Jack Britts, president and CEO of Merz Pharmaceuticals commented that this is an important regulatory milestone for Xeomin and is key to establishing the company's neurology business in the US.

"We at Merz understand, and are committed to, addressing the complexities of treating and living with these neurological disorders," Britts said.

Xeomin is the only botulinum toxin that does not require refrigeration prior to reconstitution. Merz believes this attribute will simplify product distribution and storage, and help ensure product integrity at the time of injection.

The drug will be available in 50-unit and 100-unit vials, allowing dosing flexibility for administration.

2nd August 2010

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
AMICULUM Limited

AMICULUM® is an independent global healthcare communications, consulting and learning business with a global team of >220 healthcare communications professionals,...

Latest intelligence

Ali Frederic Ben-Amor
Tackling a formidable foe
Ali Frederic Ben-Amor tells how Merck is taking the fight to multiple sclerosis...
Geoff
Cancer care – the power of new technologies
With patient numbers set to soar, how can we make a difference?...
image 1
Redefining communications excellence
How to be heard in today’s multichannel, multistakeholder, multimedia world...

Infographics