First Approval Of Astra's Colazide

23 July 1997

Astra has been granted regulatory approval in the UK for Colazide(balsalazide), a new drug for the treatment of ulcerative colitis. This is the first world approval for the drug, which is a prodrug of 5-aminosalicylic acid, a long-standing treatment for the disease.

Launch of the product in the UK is planned for the second half of 1997. The UK is acting as rapporteur for the European Union under the mutual recognition procedure, and introductions in other European countries are expected through 1998.

Balsalazide is one of six product launches scheduled for 1997 from Astra, which are integral to the company's efforts to grow the business in the face of the upcoming patent expiry for its best-selling drug Losec (omeprazole) in 2001 (Marketletters passim). Astra licenses balsalazide from Salix Pharmaceuticals of the USA in all markets except Japan and certain southern European countries.

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