PPD Shortage Prompts CDC to Issue New Recommendations for TB Testing
The CDC announced an expected 3 to 10 month shortage of Aplisol used as an aid in the diagnosis of tuberculosis.
All articles by Diana Ernst, RPh
FDA Panel Votes on Treatment for Extensively Drug-Resistant, Multidrug-Resistant TB
The FDA’s Antimicrobial Drugs Advisory Committee voted in favor of pretomanid, as part of a combination regimen with bedaquiline and linezolid, for the treatment of pulmonary extensively drug resistant, treatment intolerant, or nonresponsive multidrug resistant tuberculosis.
Mepolizumab Approved for Self-Administration Via Autoinjector, Prefilled Safety Syringe
The Food and Drug Administration has approved two new self-administration options for Nucala.
Ceftolozane and Tazobactam Approved to Treat Hospital-Acquired and Ventilator-Associated Pneumonia
The FDA has expanded the approval of Zerbaxa to include treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in pediatric patients.
First Anticoagulant Approved to Treat Symptomatic VTE in Pediatric Patients
The FDA has approved Fragmin, a low molecular weight heparin, for the treatment of symptomatic venous thromboembolism to reduce the recurrence of VTE in pediatric patients 1 month of age and older.
Budesonide-Formoterol Reliever Therapy Beats Albuterol for Prevention of Asthma Exacerbations
When used as needed, the combination of budesonide-formoterol was found to be superior to albuterol for the prevention of asthma exacerbations in patients with mild asthma.
Glass Fragment Prompts Recall of Immunosuppressive Agent
Par is recalling 1 lot of Mycophenolate Mofetil for Injection following the discovery of a glass fragment within a reconstituted vial.
Ryaltris Safe, Effective for Pediatric Patients in Seasonal Allergic Rhinitis Trial
A new PDUFA date for the treatment is now June 21, 2019; the FDA did not request additional studies from the Company.
Trelegy Ellipta Improves Lung Function in Patients With Uncontrolled Asthma
Results from a phase 3 trial evaluating Trelegy Ellipta in patients with uncontrolled asthma showed that the single inhaler triple therapy provided a significant improvement in lung function.
Ivacaftor Approved for Cystic Fibrosis in Children as Young as 6 Months of Age
The FDA has expanded the indication for Kalydeco to include treatment of cystic fibrosis in patients 6 months of age and older.
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