Allergan plc says the FDA has approved a label expansion of its anti-infective drug, Avycaz, in pediatric patients. The drug is now approved as monotherapy for complicated urinary tract infections (cUTI), and in combination with metronidazole for complicated intra-abdominal infections (cIAI).
This is the first drug to receive approval for pediatric patients with cUTI or cIAI in more than a decade. The drug is already approved in adult patients with similar indications.So far this year, Allergan’s shares have outperformed the industry. The stock has rallied 12.8% in the period, compared with the 11.6% gain for the industry.