BRIEF—Pfizer NDA for Zinforo not approved by China's regulator

US pharma giant Pfizer's New Drug Application (NDA) for injectable antibiotic Zinforo (ceftaroline fosamil) did not get approval in China.

It is not clear if it was rejected by China's Center for Drug Evaluation (CDE) or the company withdrew the application.

Pfizer acquired rights to Zinforo, along with two other antibiotics, from AstraZeneca in 2016 in an up to $1.5 billion deal.

Pfizer still has two drugs waiting for China's NDA approval.

These are the antifungal drug Cresemba (isavuconazonium sulfate) injection and capsules, and the ADC Besponsa (inotuzumab ozogamycin) for acute lymphoblastic leukemia.