Pharmacia Zyvox pediatric filing
This article was originally published in Pharmaceutical Approvals Monthly
FDA accepts for filing Pharmacia's pediatric sNDA for Zyvox (linezolid) for the treatment of gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus. The supplement was submitted June 24 and will receive priority review, establishing a user fee review goal around Christmas. Zyvox was approved for adult use April 18, 2000, for treatment of vancomycin-resistant Enterococcus faecium infections, nosocomial-acquired pneumonia (including cases due to methicillin-resistant S. aureus), community-acquired pneumonia, and complicated and uncomplicated skin and skin structure infection
You may also be interested in...
Pear Therapeutics’ Somryst insomnia treatment tool has become the first FDA-cleared product that was reviewed through the agency’s Software Precertification Pilot Program.
CNS specialist Neuraxpharm has struck a deal with Israel’s Panaxia to market medical cannabis products in Europe, starting in Germany.
The AAM has warned the Trump administration that ‘Buy American’ requirements on medicines could limit patient access to affordable medicines and increase the risk of drug shortages during the coronavirus pandemic.