Bioject receives FDA communication on use of jet injectors with flu vaccines

Oct 24 2011

Bioject Medical Technologies Inc. (OTCBB:BJCT), a leading developer of needle-free drug delivery systems, today announced that the Food and Drug Administration (FDA) has issued a communication on the use of jet injectors with influenza vaccines. The FDA is advising health care professionals not to use injector devices to administer influenza vaccines. Furthermore, the FDA recommends that all vaccines, including influenza, be administered in accordance with their labeling.

"The FDA communication on the use of jet injectors with influenza vaccines was surprising given that Bioject's Needle-Free Injection Devices, the Biojector® 2000 and the Bioject® ZetaJet™, are both FDA 510(k) cleared with indications for use that describe their use in delivery of subcutaneous (SC) or intramuscular (IM) injections of vaccines and other injectable drugs," said Ralph Makar, Bioject's President and CEO. "We are looking into the matter to better understand the situation and the FDA's concerns. A number of Bioject's Needle-Free Injection devices have been on the market for many years and we are committed to resolving this matter with the FDA in a timely manner."