Actavis’ Avycaz Approval Shows How FDA Handles Limited-Data, Limited-Use Antibiotic

FDA grants approval to two of three indications for gram-negative antibiotic based on Phase II data but follows its advisors in rejecting a third indication that came without human data, offering hints of what the limitations and possibilities of a formal limited population antibiotic approval pathway might look like.

Allergan PLC/AstraZeneca PLC received a limited use indication for the gram-negative antibiotic Avycaz (ceftazidime/avibactam), setting up a test-run for how FDA may handle a formal limited-population drug approval pathway.

The combination antibiotic was cleared Feb. 25 based on Phase II data, for use in adults with complicated intra-abdominal infections...

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