Diana Ernst, RPh

In clinical trials, tafenoquine, an 8-aminoquinoline, demonstrated efficacy against 2 primary types of malaria, Plasmodium vivax and P. falciparum malaria.

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.

The approval of Trogarzo was supported by a clinical trial (N=40) of heavily treatment-experienced adults with multidrug resistant HIV-1 infection who continued to have high levels of HIV RNA in their blood despite antiretroviral therapy.

A phase 3 study evaluating HIV patients who switched to treatment with Biktarvy found this combination therapy to be statistically noninferior to a regimen containing abacavir,

The recommendation was made after the FDA reviewed the results of a 10-year follow-up of the CLARICOR trial, which investigated the effects of clarithromycin in patients with stable coronary heart disease.

The recommendation follows the presentation of positive results from a US study in children between the ages of 2 to <4 years evaluating the shedding and antibody responses of the H1N1 strain in the live attenuated influenza vaccine.

The FDA approval of Heplisav-B was based on data from 3 phase 3 noninferiority trials involving close to 10,000 adults who received the vaccine.

Individuals who have previously received 2 doses of a mumps-containing vaccine should receive a third dose if at increased risk for developing mumps.

A new immunotherapy approach has shown promise in it’s first-in-human trial for antibiotic-resistant bacteria.

The CDC has stated that supply of the adult hepatitis A vaccine is currently constrained due to ongoing outbreaks in US cities.

FDA posts a notification for a voluntarily recall of a diabetes drug over microbial contamination.

Updated labeling has been provided for several treatments for hepatitis C virus infections.

The FDA approves new hepatitis B virus vaccine for adults.

Vabomere is now available for the treatment of adults (≥18 years old) with complicated urinary tract infections.

The recommendations will be published in the November issue of the American Journal of Obstetrics and Gynecology.

For uncomplicated Gram-negative bloodstream infections, oral beta-lactam therapy may be an appropriate stepdown option.

Merck announced that the development programs for two hepatitis C virus infection treatments have been discontinued.

The FDA has approved the first oral treatment for bacterial vaginosis.

The ACIP issued new guidelines for the upcoming influenza season including not using live attenuated influenza vaccine because of concerns of effectiveness.

The FDA has updated its list of resolved CBER-regulated product shortages to alert the public that the tetanus and diphteria vaccine shortage has been resolves.

Ceftin Oral Suspension, an antibiotic, has been discontinued.

GlaxoSmithKline has initiated a voluntary recall of Menveo vaccine for meningitis for intramuscular injection.