Submitted by Aspergillus Administrator on 4 April 2014
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration has approved NOXAFIL® (posaconazole) injection (18 mg/ mL), a new formulation of NOXAFIL for intravenous (IV) use. Merck’s antifungal agent is also marketed as NOXAFIL (100 mg) delayed-release tablets and NOXAFIL (40 mg/mL) oral suspension. NOXAFIL injection, delayed-release tablets and oral suspension are indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia (low white blood cell counts) from chemotherapy.
NOXAFIL injection is indicated in patients 18 years of age and older. NOXAFIL delayed-release tablets and oral suspension are indicated in patients 13 years of age and older. With this approval, Merck now provides an IV formulation and two oral formulations of NOXAFIL for prophylaxis against invasive Aspergillus and Candida infections in high-risk patients. – See more at: http://www.mercknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-noxafil-posaconazole-injection-18-mgml-I#sthash.kxV0QM7t.dpuf
“Merck is pleased to add NOXAFIL injection to the NOXAFIL family of products. The availability of a NOXAFIL formulation for intravenous administration is particularly important for those patients who may benefit from or require intravenous therapy, or who, for a variety of reasons, might not be able to take an oral formulation. In addition, patients have the possibility to start on NOXAFIL injection and transition to oral NOXAFIL,” said Dr. Nicholas Kartsonis, executive director, Infectious Disease, Merck Research Laboratories.
In clinical trials, the adverse reactions reported for NOXAFIL IV injection were generally similar in type to that reported in trials of NOXAFIL oral suspension. The most frequently reported adverse reactions with an onset during the posaconazole intravenous phase of dosing 300 mg once-daily therapy were diarrhea (32%), hypokalemia (22%), fever (21%) and nausea (19%).
NOXAFIL injection is expected to be available at wholesalers in mid-April.
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