Sivextro Approval Expanded to Include Pediatric Patients
The FDA has expanded the approval of Sivextro.
Bacterial Infections
Household Transmission of MRSA Skin and Soft Tissue Infections
Household environment plays a key role in the transmission of community-associated methicillin-resistant Staphylococcus aureus (MRSA) skin and soft tissue infections.
Teflaro Approved for Younger Patients to Treat Acute Bacterial Skin/Skin Structure Infections
The FDA has expanded the indication for Teflaro (ceftaroline fosamil; Allergan) to include treatment of acute bacterial skin and skin structure infections in pediatric patients.
16S rDNA PCR Improves Bacterial Pyomyositis Diagnosis
Using a broad-range PCR technique targeting 16S ribosomal DNA may improve diagnosis and treatment of bacterial pyomyositis.
Bacteremia Risk in Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis
Prediction of sepsis via markers such as hypothermia and elevated procalcitonin
may allow for its early detection and management.
FDA Issues Complete Response Letter Rejecting Iclaprim Approval for ABSSSI
The NDA included data from the Phase 3 REVIVE-1 and REVIVE-2 trials.
Progress Made in Developing New Antibacterial Agents
Although there has been progress in the development of new antibacterial drugs, most of the recently approved agents have been modifications of existing chemical classes of antibiotics.
Nuzyra Now Available in IV, Oral Forms for CABP, ABSSSI
Nuzyra, an aminomethylcycline (related to tetracycline antibiotics), is designed to overcome tetracycline resistance and has broad-spectrum activity against Gram-positive, Gram-negative and atypical bacteria, and other drug-resistant strains.
Omadacycline Noninferior to Moxifloxacin in CABP Study, Linezolid in ABSSSI Study
Omadacycline is noninferior to moxifloxacin for community-acquired bacterial pneumonia and noninferior to linezolid for acute bacterial skin infections.
Nuzyra Approved for CABP, Acute Skin/Skin Structure Infections
The approval was based on Phase 3 data from 2 studies in ABSSSI, where treatment with Nuzyra was compared with linezolid, and 1 study in CABP comparing Nuzyra with moxifloxacin. Across all 3 trials, Nuzyra was found to be effective and generally safe and well-tolerated.
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