Allergan To Pay $600 Million in Fines Regarding Botox

First, it was used to treat strabismus and blepharospasm, two eye muscle disorders. Later it was used to reduce wrinkles, as well as cure migraine headaches and treat hyperhidrosis and incontinence. But while some may call it a wonder drug, it’s no wonder why regulators took a long hard look at Botox(onabotulinumtoxinA) and has fined the product’s maker, Allergan, hundreds of millions of dollars.

Yesterday, Allergan agreed to plead guilty to a single misdemeanor “misbranding” charge covering the period 2000 through 2005 and pay to the Government $375 million.

In addition, Allergan has agreed to pay $225 million to resolve civil claims asserted by the U.s. Department of Justice under the civil False Claims Act. The civil settlement is an element of a global settlement that Allergan believes is in the best interest of its stockholders. However, Allergan denies liability associated with these civil allegations and does not believe there is merit to them factually or legally.

Botox was first approved by the FDA 20 years ago for the treatment of strabismus and blepharospasm, two eye muscle disorders, making it the first botulinum toxin type A product approved in the world. Since its first approval, Botox has been recognized by regulatory authorities worldwide as an effective treatment for 21 different indications in approximately 80 countries.