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FDA gives nod to APP Pharma Piperacillin, Tazobactam for injection

The US Food and Drug Administration (FDA) has granted approval to APP Pharmaceuticals for marketing Piperacillin and Tazobactam for injection.

Piperacillin and Tazobactam for injection is therapeutically equivalent to Pfizer Injectables’ marketed product, Zosyn.

Piperacillin and Tazobactam for injection is indicated for the treatment of patients with moderate to severe infections caused by piperacillin-resistant, susceptible strains of indicated organisms.

The injection is also used to treat appendicitis (complicated by rupture or abscess) and peritonitis, uncomplicated and complicated skin and skin structure infections, postpartum endometritis, community-acquired pneumonia of moderate severity only, and nosocomial pneumonia (moderate to severe).

APP will package Piperacillin and Tazobactam for Injection in 2.25g, 3.375g and 4.5g single dose vials, and in a 40.5g pharmacy bulk package.

APP president and CEO John Ducker said the approval enables them to continue their commitment of bringing affordable medications to hospitals, clinics and long-term care facilities throughout the US.