Below is a summary of updates to the
BioMedReports.com database of over 200 entries included in the
FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results (with a focus on late-stage, Phase 3 trials), pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), and pending re-submissions to the FDA for complete response rulings by the agency which require more information before an approval can be granted.
Cadence Pharma (NASDAQ:CADX): On 5/14/09, CADX announced the 505(b)(2) NDA submission for Acetavance (the Company's proprietary intravenous formulation of acetaminophen) for the treatment of acute pain and fever in adults and children. If approved, Acetavance would become the first new intravenous analgesic approved in the U.S. in more than 20 years and the only approved intravenous agent for the treatment of fever in this country.
The NDA filing includes data from one pivotal clinical trial for the treatment of acute pain in patients following orthopedic surger, one pivotal clinical trial for the treatment of endotoxin-induced fever, and is also supported by data from a total of nine placebo-controlled clinical trials, four active-controlled clinical trials, and seven other safety or pharmacokinetic clinical trials. The submission includes safety data from over 1,400 patients who received Acetavance in clinical trials, including 350 children, and data from safety reports that collectively represent more than 53 million patient exposures to intravenous acetaminophen in countries outside the United States.
Novartis (NYSE:NVS): Novartis announced today that Prevacid 24HR (lansoprazole delayed-release capsules 15 mg) has been approved by the FDA as the first over-the-counter (OTC) Proton Pump Inhibitor (PPI) for the treatment of frequent heartburn since 2003 (Prilosec OTC). Prevacid 24HR is expected to be available over-the-counter later this year.
Osmetech (LON:OMH) announced today that it has submitted a request to the FDA for Emergency Use Authorization for its Respiratory Pathogen Test Panel test to be used to screen for the swine flu virus.
