The FDA has approved Rukobia (fostemsavir; ViiV Healthcare), in combination with other antiretrovirals, for the treatment of HIV-1 infection in heavily treatment-experienced adults with multidrug-resistant HIV-1 infection failing their current antiretroviral regimen due to resistance, intolerance, or safety considerations.
All articles by Diana Ernst, RPh
Hand sanitizers containing methanol, or wood alcohol, present a danger to individuals as the substance can be toxic when absorbed through the skin or life-threatening if ingested.
Descovy reached intracellular drug concentration levels above the estimated protective threshold significantly faster than Truvada.
In 2012, the FDA established the Truvada REMS for PrEP which required manufacturers to provide training materials, now that is no longer needed.
According to results from the MINISTONE-2 trial, baloxavir marboxil (Xofluza) was found to be safe and effective in children 1 to less than 12 years old with an influenza infection.
The Centers for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP) has voted to recommend that pediatric patients (2 to 18 years old) who have not previously received hepatitis A vaccine be routinely vaccinated at any age. Currently, the CDC recommends routine hepatitis A vaccination for children 12 to 23 months of…
The pediatric approval was based on data from an open label, single arm trial that evaluated the efficacy, safety, and pharmacokinetics of Biktarvy in virologically suppressed children (6 to <12 years old; n=50) and adolescents (12 to <18 years old; n=50).
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.
The CDC announced an expected 3 to 10 month shortage of Aplisol (tuberculin purified protein derivative [PPD], diluted), used as an aid in the diagnosis of tuberculosis.
The NDA for Talicia for the treatment of Helicobacter pylori (H. pylori) infection has been submitted to the FDA by RedHill Biopharma.
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.
A recall of Ketorolac Tromethamine Injection has been issued following microbial growth contamination.
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.
A new clinical guideline on the diagnosis and treatment of recurrent urinary tract infections in women was released by AUA.
The NDA for the long-acting injectable formulation of rilpivirine + cabotegravir (Janssen and ViiV Healthcare) for HIV has been submitted.
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.
The FDA has expanded the approval of Avycaz to include pediatric patients aged ≥3 months for the treatment of complicated intra-abdominal infections.
A study shows Descovy for PrEP demonstrated that the treatment was non-inferior to Truvada for HIV prevention.
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).
The information, posted to the Food and Drug Administration (FDA) website, states that both the Recombivax HB adult (10mcg/mL) and dialysis (40mcg/mL) formulations are not expected to be available in 2019.
For this study, the authors identified randomized controlled trials that compared SGLT2 inhibitors with placebo, no treatment, or another antidiabetic agent and reported on UTI outcome.
Aemcolo is a broad spectrum, semi-synthetic, orally-administered, minimally-absorbed antibiotic designed to allow for delayed release to the colon.
The vaccines are indicated for active immunization against influenza disease caused by virus subtypes A and type B present in the vaccine.
“This is the first new antiviral flu treatment with a novel mechanism of action approved by the FDA in nearly 20 years,” said FDA Commissioner Scott Gottlieb, MD.
The 68-year-old patient reported having a fever for 1 week followed by progressive, painful swelling on the right side of his neck for 2 months.
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.
Arikayce is intended for oral inhalation use and is administered via the Lamira Nebulizer System only.
The patient, a 42-year-old female with systemic lupus erythematosus treated with mycophenolate mofetil and prednisone, reported swelling and pain in the fifth finger of her left hand for about 1-week.
In general, routine annual vaccination is recommended for all patients ≥6 months of age who have no contraindications.
The FDA has approved Mulpleta for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.
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