The FDA told Johnson & Johnson that additional clinical studies are required before the agency will consider approving antibiotic ceftobiprole. It's the latest setback for the J&J and its development partner, Swiss biotech Basilea Pharmaceutica AG, over the anti-infective, whose US approval for treating complicated skin and skin structure infections (cSSSI) has been pending since May 2007. “We're going to meet with [FDA] to talk about the path forward,” said a J&J spokesman. “That could include new trials, but it hasn't been determined yet.” J&J received an approvable letter for ceftobiprole in March 2008 and an initial complete response letter the following November, in which the agency asked that the firm conduct audits of its trial sites. J&J, which licensed ceftobiprole in 2005 from Basilea, said it responded to both letters. Basilea issued its own statement on the delay, saying the FDA warned J&J earlier this year that its US partner had “failed to adequately monitor” investigator conduct in the studies. Dr. Anthony Man, Basilea CEO, said his firm is committed to making the drug more widely available. Regulatory review in the EU is ongoing, with a decision expected in early 2010. Basilea also said it took the case to arbitration last February, claiming J&J caused the delay and seeking “significant” damages.
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