Schering-Plough Europe has pulled its regulatory dossier for the anti-infective agent garenoxacin mesylate in Europe, after the region’s scientific advisory panel – the Committee for Medicinal Products for Human Use – sought new information.
The marketing application was submitted in May last year for two oral and one infusion dose of garenoxacin, which is designed for use in a broad sweep of infections, including acute bacterial exacerbation of chronic bronchitis, acute bacterial sinusitis, community-acquired pneumonia and uncomplicated skin and skin structure infections.
In its official letter, the company stated that the withdrawal was based on the CHMP’s request for additional information, to which the company was unable to respond within the permitted timeframe. Withdrawal of an application does not prevent a company making a new application at a later stage.
Toyama sold S-P worldwide rights to quinolone antibiotic garenoxacin for $80 million in 2004, but was left disappointed last year when the group also pulled back the application in the USA – reportedly because it had, then, failed to find a partner to help it sell the drug.
Abbott withdraws Trudexa
Meanwhile, the European Medicines Agency has withdrawn the marketing authorization for Abbott’s arthritis drug Trudexa on the company’s request. The agent was approved on 1 September, 2003, for the treatment of rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis but was never marketed. Abbott requested the marketing authorisation be withdrawn for commercial reasons.
