Johnson & Johnson’s bid to get a second approval for the antibiotic Doribax is on hold after regulators said they need more time to look at the application.

J&J is trying to get the green light for Doribax (doripenem), which is already approved to treat complicated urinary tract and intra-abdominal infections, is now looking to get approval for the drug as a treatment for nosocomial or ‘hospital-acquired’ pneumonia as well as ventilator-associated pneumonia. However the US Food and Drug Administration extended the review period for Doribax in this new indication in order to review additional information it had requested from the company.

The new application was submitted in June 2007 but the FDA’s desire for more time to look at the new data means that the review period has been extended by three months. Doribax, which is licensed from Japanese drugmaker Shionogi, is currently is under regulatory review in Europe, Canada and in other countries.

This latest day comes less than a month after the FDA has cancelled a meeting of its anti-infective drugs advisory committee, scheduled for February 28, which was going to review another J&J antibiotic ceftobiprole, which is being co-developed with Switzerland’s Basilea Pharmaceutica. No reason was given by the agency for the cancellation of the meeting about ceftobiprole which has been filed for the treatment of complicated skin and skin structure infections, including diabetic foot infections.