In clinical trials, tafenoquine, an 8-aminoquinoline, demonstrated efficacy against 2 primary types of malaria, Plasmodium vivax and P. falciparum malaria.
All articles by Diana Ernst, RPh
The FDA has granted Fast Track designation to a novel antiviral in development for the treatment of HBV infection.
Findings from the study were presented at the 22nd International AIDS Conference (AIDS 2018) in Amsterdam.
Zemdri carries a Boxed Warning describing reports of nephrotoxicity, ototoxicity, and neuromuscular blockade, as well as fetal harm if administered during pregnancy.
The approval of Intelence for this patient population was based on an open-label, single arm trial (N=20) which showed that the safety and efficacy of etravirine + an optimized background regimen (ritonavir-boosted protease inhibitor in combination with 1 or 2 NRTIs [N=14] and/or combination with an integrase inhibitor [N=7]) was comparable to that observed in adults.
The labeling changes are based on a review of postmarketing adverse event reports found in the FDA Adverse Event Reporting System (FAERS) database and published medical literature.
The case involved a 68-year-old female patient with rheumatoid arthritis on methotrexate 10mg weekly who presented to the emergency department with complaints of lethargy and weakness after being prescribed a 2-week course of TS for a bacterial skin infection.
The NDA includes safety and efficacy data from two Phase 3 trials (REVIVE-1 and REVIVE-2; N=1190) which compared intravenous iclaprim to standard-of-care vancomycin in patients with ABSSSI.
The guidelines were developed by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America.
Doptelet was approved for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.