Delay to ceftobiprole's US approval
The US Food and Drug Administration has issued an "approvable" letter for health care major Johnson & Johnson's antibiotic ceftobiprole. According to Lehman Brothers' analysts, the issues raised by the agency could delay the drug's potential approval by up to 12 months. Their new expected US launch date for the compound in complicated skin and skin structure infections is now in the second half of 2009 and they anticipate the letter to have limited impact to a filing in pneumonia.
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