New Haven, CT (PRWEB) September 11, 2014
New Haven Pharmaceuticals, Inc. (the “Company”), a privately held specialty pharmaceuticals company, today announced the submission of a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) on September 5, 2014 covering its lead drug product, DURLAZA™.
DURLAZA is being developed to assist the more than 25 million people in the US being treated for the secondary prevention of stroke and acute cardiovascular events (to reduce the risk of stroke or acute cardiac events in patients who have suffered a prior stroke or acute cardiac event).
“Assuming timely review under the Prescription Drug User Fee Act (“PDUFA”) and FDA approval of the NDA, we expect to launch DURLAZA in the United States in the third quarter of 2015,” said Patrick Fourteau, Chief Executive Officer of New Haven Pharmaceuticals.
About New Haven Pharmaceuticals, Inc.
New Haven Pharmaceuticals Inc. (NHP) is a specialty pharmaceuticals company developing new prescription drug products that utilize currently marketed drugs or generally recognized as safe (GRAS) active pharmaceutical ingredients (APIs) for use in therapeutic applications representing attractive market opportunities. In addition to DURLAZA, NHP is developing products incorporating proprietary Yale University technology utilizing zinc salts, including both a proprietary zinc salts product designed to lower stomach acid in patients suffering from gastro-esophageal reflux disease (or GERD) and a combination product with DURLAZA.
For more information on NHP, please visit http://www.newhavenpharma.com.
DURLAZA is a trademark of New Haven Pharmaceuticals Inc.
Harry H. Penner, Jr.