NDA for Cominbation Rifabutin/Amoxicillin/Omeprazole Capsule for H pylori Submitted to FDA
The NDA for Talicia for the treatment of Helicobacter pylori (H. pylori) infection has been submitted to the FDA by RedHill Biopharma.
All articles by Diana Ernst, RPh
Glecaprevir/Pibrentasvir Approved to Treat All 6 Genotypes of HCV in Pediatric Patients
The FDA has approved Mavyret for the treatment of all 6 genotypes of hepatitis C virus in children 12 to 17 years old or weighing at least 45kg.
Injectable Ketorolac Recalled Due to Possible Microbial Contamination
A recall of Ketorolac Tromethamine Injection has been issued following microbial growth contamination.
First Vaccine Approved to Protect Against Dengue in Endemic Areas of the US
The Food and Drug Administration (FDA) has approved Dengvaxia (dengue tetravalent vaccine, live; Sanofi) for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4.
Recommendations for the Evaluation, Management of Recurrent UTI in Women Released
A new clinical guideline on the diagnosis and treatment of recurrent urinary tract infections in women was released by AUA.
NDA for Once-Monthly Injectable HIV Treatment Submitted to FDA
The NDA for the long-acting injectable formulation of rilpivirine + cabotegravir (Janssen and ViiV Healthcare) for HIV has been submitted.
DRESS Associated With Agranulocytosis in a Patient Treated With Oxacillin
A recent report published in the American Journal of Case Reports describes a rare case of drug reaction with eosinophilia and systemic symptoms (DRESS)-induced agranulocytosis in a patient treated with the beta-lactam antibiotic oxacillin.
Ceftazidime/Avibactam Approved for Pediatric Use to Treat Complicated Intra-Abdominal, UTIs
The FDA has expanded the approval of Avycaz to include pediatric patients aged ≥3 months for the treatment of complicated intra-abdominal infections.
DISCOVER Study Finds New Dual NRTI Pill Noninferior to Current Combo
A study shows Descovy for PrEP demonstrated that the treatment was non-inferior to Truvada for HIV prevention.
Adacel Approved for Repeat Vaccination Against Tetanus, Diphtheria, Pertussis
The approval was based on data from the Td537 study which included individuals 18-64 years old who had received a dose of Adacel 8-12 years prior (N=1330).
Next post in Prevention
