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Botox is most famous for its ability to smooth frown lines on aging foreheads, but the drug -- introduced in 1989 -- is also approved to treat neck spasms, eye muscle disorders and excessive underarm sweating.
Last year the drug won approval to treat spasms in the elbows, wrists and fingers. The drug is also widely used off-label to treat cerebral palsy in children as well as in adults, and Allergan says it is in discussions with U.S. health regulators to approve the use of Botox for children with the neuromuscular disorder.
In guidelines published earlier this year, the American Academy of Neurology endorsed Botox as an "effective and generally safe treatment" for children with cerebral palsy. While the use is not approved by the Food and Drug Administration, the guidelines stated that there are more studies supporting Botox than other movement-disorder drugs.
Botox works by blocking the connections between nerves and muscle, temporarily paralyzing muscles that cause wrinkles as well as certain types of spasms. The drug is a purified form of botulinum, one of the most toxic substances in the world.
As part of the settlement, Allergan agreed to drop a lawsuit against the FDA in which the company pressed for greater leeway to discuss off-label uses with doctors.
The company argued it had a First Amendment right to educate doctors about how to safely use Botox, even for uses that are not currently approved. FDA's rules are designed to stop companies from promoting drugs for uses that haven't been federally confirmed as safe and effective.
Some legal experts speculated that Allergan's lawsuit against FDA was primarily aimed at gaining leverage in its negotiations with the Justice Department, which was a separate matter.
Shares of Allergan rose $1.86, or 3 percent, to $63.28.
Copyright 2010 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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