Amended: replaces "ZINFOROTM" with "ZINFORO" in the headline and entire article.
AstraZeneca (AZN: Quote) announced the European Commission has granted Marketing Authorisation to ZINFORO, or ceftaroline fosamil, a new intravenous cephalosporin antibiotic, for the treatment of adult patients with complicated Skin and Soft Tissue Infections or Community Acquired Pneumonia. AstraZeneca said the authorisation makes ZINFORO the only approved cephalosporin monotherapy in Europe with demonstrated clinical efficacy against methicillin-resistant Staphylococcus aureus.
The Marketing Authorization of ZINFORO is based on data from the Phase III clinical trial programme which included four pivotal registration trials, CANVAS 1 and 2 and FOCUS 1 and 2. AstraZeneca said the studies demonstrated consistent clinical efficacy in the treatment of cSSTI and CAP with the recognised tolerability profile of the cephalosporin class.
In 2009, Forest Laboratories Inc. granted AstraZeneca exclusive worldwide commercial rights and co-exclusive development rights for ceftaroline fosamil, excluding US, Canada and Japan. Forest launched ceftaroline fosamil with similar indications under the trade name Teflaro in the US in March 2011.
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by RTT Staff Writer
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