Pfizer's Ceftaroline Fosamil for Injection Not Approved in China

By Baihuawen

NMPA’s August 3 Notice on Drugs Awaiting Collection Indicates That Pfizer’s Cefroperazone for Injection Has Not Been Approved in China, Possibly Due to Voluntary Withdrawal by the Company, Non-Approval, or Other Reasons

Ceftaroline fosamil is a fifth-generation cephalosporin antibiotic that received FDA approval for marketing in October 2010 under the brand name Zinforo. Clinically, it is primarily indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP). AstraZeneca previously held the global commercialization rights for Zinforo, with the exceptions of North America and Japan, where the rights were held by Allergan and Takeda, respectively.

In August 2016, Pfizer acquired the rights to market several anti-infective drugs, including Zinforo, from AstraZeneca in markets outside the United States, for an upfront payment of $550 million, deferred payments of $175 million, milestone payments of up to $250 million, sales-related payments of $600 million, and subsequent sales royalties.

In the field of anti-infective therapy, Pfizer has currently submitted marketing applications in China for isavuconazonium sulfate capsules, isavuconazonium sulfate for injection, and inotuzumab ozogamicin for injection, which are currently under review.