Botox cleared for neck pain in USA

2 January 2001

Allergan has been awarded approval in the USA to market its Botox(botulinum toxin Type A) for the treatment of adults with cervical dystonia, a neurological movement disorder characterized by involuntary muscle contractions that force the head and neck into abnormal and sometimes painful positions.

Botox has also been approved by regulatory agencies in 40 other countries as a treatment for CD and has been marketed for over 10 years in the USA. The new approval is significant, however, as it keeps Botox on level terms with Elan's newly-approved Myobloc (botulinum toxin type B), which was registered for CD in the USA towards the end of last year (Marketletter December 18, 2000). Although Myobloc is only approved for CD, while Botox is also registered for blepharospasm and strabismus, the level of off-label use with this type of product, for example to reduce wrinkles, has led analysts to suspect that Elan's product may cut into Botox' market share.

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