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FDA Accepts for Filing a Biologic License Application (BLA) for Dysport(R) in Cervical Dystonia |
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31 Jan 2008 |
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This acceptance signifies the start of the review process of the dossier
PARIS, France | January 31, 2008 | Ipsen (Euronext: FR0010259150; IPN) today announced that the Food and Drug Administration (FDA) has accepted the filing of its BLA for Dysport® in the United States to treat patients with cervical dystonia. This acceptance signifies the start of the review process of the dossier.
About Dysport®
The active substance in Dysport® is a botulinum neurotoxin type A complex, which acts at the level of the neuromuscular junction in the targeted muscle. Dysport®, Ipsen’s botulinum toxin type A, is a neuromuscular blocking toxin which acts to block acetylcholine release at motor nerve ends and reduces muscular spasm. It was initially developed for the treatment of movement disorders such as cervical dystonia (a chronic condition in which the neck is twisted or deviated), blepharospasm (involuntary eye closure), hemifacial spasm and various forms of muscle spasticity, including post-stroke arm spasticity, spasticity of the lower limbs (calf) in adults and children with cerebral palsy. Dysport® was originally launched in the United Kingdom in 1991 and has marketing authorisations in over 70 countries.
The product is currently referred to as Reloxin® in the United States aesthetic market and Dysport® for medical and aesthetic markets outside the U.S.
SOURCE: IPSEN
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