FDA Approves TEFLARO® (ceftaroline fosamil) of Allergan for Pediatric Patients


May 31, 2016

Allergan has announced that the Food and Drug Administration(FDA) has approved the supplemental New Drug Application (sNDA) of the company named TEFLARO® (ceftaroline fosamil). This can be applied to pediatric patients 2 months of age to less than 18 years of age with acute bacterial skin and skin structure infections (ABSSSI). These include infections caused by methicillin-resistant Staphylococcus aureus (MRSA), and community-acquired bacterial pneumonia (CABP) caused by Streptococcus pneumoniae and other designated susceptible bacteria.

David Nicholson, Chief R&D Officer, Allergan, said: “The impact of ABSSSI and CABP among children is significant, as these infections often require hospitalization and are met with limited pediatric treatment options, particularly as resistance increases among the pathogens that cause these infections. These new indications are yet another testament to our ongoing research and development in anti-infectives to address the evolving challenges of serious infections. Importantly, it allows us to educate physicians on the data they need to prescribe TEFLARO to appropriate pediatric patients in need of an option that is safe and effective against some of the most difficult-to-treat pathogens in ABSSSI and CABP.”

CABP and ABSSSI are common causes of healthcare visits and hospitalizations among children. Recent studies show that over 70,000 hospitalizations for ABSSSI occur among children per year. This rate that has more than doubled over the past 13 years.


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