We are very pleased to co-promote COLAZAL with Salix," stated Lonnel Coats, President and Chief Operating Officer, Eisai, Inc.
Safety and effectiveness of COLAZAL beyond 8 weeks in children (ages 5-17 years) and 12 weeks in adults has not been established.
prescriptions for the first nine months of 2007 remained stable compared to the first nine months of 2006 - commendable performance in the highly competitive 5-ASA marketplace.
Since regaining the marketing rights to COLAZAL from our former partner, AstraZeneca, in December 1999, Salix has focused on expanding its infrastructure to manufacture COLAZAL in commercial quantities and to market the product in the United States directly through our specialized sales force,'' said Robert Ruscher, President and Chief Executive Officer of Salix.
FDA approval of COLAZAL is terrific news for patients who suffer from mild to moderate ulcerative colitis as they will have an innovative new product available as a first-line therapy to treat their active disease,'' said Randy Hamilton, Chairman of the Board and co-founder of Salix.
Let's take a closer look at what Salix has said about Colazal
The Company is planning to invest approximately $105 million in selling, general and administrative activities during 2008, in anticipation of the launch of one product and pre-launch of two products during the year, as well as costs related to protecting our COLAZAL business.
The increase in 2007 selling, general and administrative expenses was primarily related to pre-launch activities for balsalazide tablet and granulated mesalamine and a small, one-time write-off associated with COLAZAL samples.
(balsalazide disodium) Capsules 750 mg is an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis.
Food and Drug Administration approved a supplemental new drug application which provides for changes to the approved labeling for COLAZAL
based upon the pharmacokinetics of COLAZAL
administered with food as well as sprinkled over food.
The downdraft followed news that the drug developer's Colazal
treatment for ulcerative colitis faces generic competition from three companies.
6 million charge related to generic competition over the ulcerative colitis drug Colazal
, the company earned 32 cents per share on revenue of $71.