Meronem is indicated for the treatment of the following infections in adults and children aged 3 months and older (see sections 4.4 and 5.1): • Severe pneumonia, including hospital and ventilator-associated pneumonia. • Broncho-pulmonary infections in cystic fibrosis • Complicated urinary tract infections • Complicated intra-abdominal infections • Intra- and post-partum infections • Complicated skin and soft tissue infections • Acute bacterial meningitis Meronem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above. Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Marinus Pharmaceuticals, Inc., a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, announced that an independent Data Monitoring Committee (DMC) has recommended continuing the pivotal Phase III RAISE trial evaluating intravenous (IV) ganaxolone for the treatment of refractory status epilepticus (RSE) following an interim analysis
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the FDA has approved Uptravi (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adult patients with WHO functional class (FC) II–III, who are temporarily unable to take oral therapy.
Shire will initiate two Phase IV clinical trials to compare Vyvanse (lisdexamfetamine dimesylate) Capsules, (CII) to Concerta� (methylphenidate HCl) Extended-Release...
Recro Pharma, Inc. announced it has received a second Complete Response Letter (CRL) from the FDA Office of Drug Evaluation...
Novartis,, announced that the FDA has approved an intravenous (IV) formulation of Cosentyx (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).
Avenue Therapeutics, Inc. a company focused on the development of intravenous (“IV”) tramadol for the U.S. market, announced that the FDA was still reviewing its New Drug Application (“NDA”) for IV tramadol and had not provided a decision regarding the NDA.
Recro Pharma, Inc. announced the publication of new intravenous (IV) meloxicam data. The article, titled �Meloxicam intravenous for the treatment...
Pfizer Inc. and Astellas Pharma Inc. announced the Phase IV PLATO study , evaluating the efficacy and safety of continued...