(FDA) An agency of the US federal government established by Congress in 1912 and presently part of the US Department of Health and Human Services. The FDA gives classifications of medical devices according to potential risks and controls the safety of marketed drugs.

See also Class I II III Devices, Phase 1 2 3 4 Drug Trials and US FDA 510k Document.

See also Imagent®.
June 19, 2003
Alliance Pharmaceutical Corporation and Photogen Technologies, Inc. announced that they have closed the previously announced transaction whereby Photogen has acquired all of the assets of Alliance related to medical imaging, including all manufacturing and marketing rights to Imagent (formerly Imavist). Terms of the transaction were not disclosed.

June 03, 2002
Alliance Pharmaceutical Corp. announced that its ultrasound imaging agent, Imagent (perflexane lipid microspheres), has been approved for marketing by the U.S. Food and Drug Administration. The product will be marketed by Alliance in partnership with Cardinal Health, Inc., a provider of products and services to the healthcare industry, and inChord Communications, Inc., an independent healthcare communications company.

March 01, 2002
'Alliance Pharmaceutical Corp. announced that it has entered into a partnership with Bayer Schering Pharma AG, Germany and Cardinal Health Inc. for the marketing of Imavist (perflexane lipid microspheres), an ultrasound contrast agent. Schering licensed worldwide marketing rights for Imavist from Alliance in September 1997. The companies have agreed to modify this agreement to allow Alliance to increase its participation in the marketing of the product. Under the terms of the modified agreement, Alliance will have exclusive marketing rights to Imavist for cardiology indications in the U.S. for five years, and Schering will receive a royalty on product sales. Schering retains marketing rights for other indications in the U.S. and all indications in the rest of the world, subject to Alliance's option to obtain additional indications and territories. Under certain circumstances, Schering would co-market the product at the end of five years. Concurrently, Alliance has entered into a five-year exclusive agreement with Cardinal Health Inc., a provider of products and services to the health-care industry, to assist in the marketing of Imavist.'

October 08, 2001
'Alliance Pharmaceutical Corp. announced a clinical study to take place at Thomas Jefferson University Hospital, Philadelphia, using Alliance's Imavist (AF0150) contrast agent with ultrasound imaging to improve detection of prostate cancer. The study, which will involve 300 adult men with suspected prostate cancer, is being funded by the U.S. Department of Defense under a competitive grant awarded to Thomas Jefferson University for investigators at Jefferson's Prostate Center. Imavist is being developed jointly by Alliance and Bayer Schering Pharma AG Germany, and is awaiting final approval from the U.S. Food and Drug Administration.'

August 21, 2000
Alliance Pharmaceutical Corp. announced that it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the FDA has completed its review of the New Drug Application (NDA) for Imagent (AF0150), and found it to be approvable. Imagent, an ultrasound contrast agent, is being developed jointly by Alliance and Bayer Schering Pharma AG, Germany

Notes:
The manufacturer is pursuing additional radiology indications such as ultrasound imaging of the prostate and liver, and clinical trials are currently being conducted to evaluate Imagent in conjunction with ultrasound imaging for use in the detection of prostate cancer. During the course of its development, the brand name for this product has changed from Imagent to Imavist back to Imagent. Initially reported on by the manufacturer as Imagent and then, between August 2000 and March 2002, as 'Imavist (formerly Imagent).' The manufacturer's 06/03/02 press release announcing FDA approval refers to the product as 'Imagent (formerly Imavist),' and the approval notice and monograph posted at the FDA site refers to the product as Imagent. Jointly developed by Alliance Pharmaceutical Corp and Bayer Schering Pharma AG, (Germany). Source: PR Newswire - 10/10/96, 03/31/98, 10/13/99, 03/13/01, 10/08/01; FDA approvals - 05/31/02; Alliance Pharmaceutical press release - 06/03/02.

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From Acusphere Inc
AI-700 (trade name Imagify™) is an US contrast agent, usable for myocardial perfusion undergoing regulatory FDA approval. The synthetic polymers used in AI-700 (perflubutane polymer microspheres) do not break during the ultrasound imaging procedure. The used perfluorocarbon filling gas is less soluble in water and therefore has the propensity to stay inside the contrast agent particles. As a result, a higher concentration of gas is delivered to the myocardium over a longer period of time, thereby enabling AI-700 to target the broader application of myocardial perfusion assessment.
Imagify is a dry powder consisting of small, porous microparticles filled with perfluoropropane. These microparticles are made of a synthetic biodegradable polymer, called poly (D, L-lactide co-glycolide), or PLGA, that has been used in other drug delivery systems approved by the FDA.
The composition and structure of the phospholipid containing microparticles and the properties of the perfluorocarbon gas slow the rate at which the gas dissolves and prevent the microparticles from being quickly broken down. The powder is to suspend in sterile water and injected by a single intravenous injection prior to ultrasound imaging.

In 2009, Acusphere Inc received feedback from the Food and Drug Administration (FDA) to their New Drug Application (NDA) stating that another clinical trial would be required for U.S. approval, this one demonstrating that Imagify with ultrasound is superior to ultrasound without Imagify.
In June 2004, Acusphere entered into a Collaboration, License and Supply Agreement with Nycomed Danmark APS for the European development and marketing rights to Acusphere's lead product candidate AI-700.
Acusphere's focus will be on preparing the Marketing Authorization Application (MAA) for filing in Q4 2010, building upon the work that the previous partner, Nycomed, had done, in concert with the NDA.


In 2008 the FDA panel rejected the regulatory application for AI-700 (Imagify™) because of safety concerns.

Breast ultrasound (sonography or ultrasonography) it is an important tool in the characterization of breast lesions, detected with mammography or clinical breast examination. However, a breast sonogram is not approved by the U.S. Food and Drug Administration (FDA) as a screening tool for breast cancer and is used additional to a mammogram.
Ultrasound is useful in guiding needles for fine needle aspiration and core biopsies. Breast ultrasound has optimal contrast resolution, but it lacks the spatial resolution of conventional mammography and cannot provide as much detail as a mammogram image. In addition, ultrasound is unable to show tiny calcium deposits (microcalcifications) that are often early indications of breast cancer.

See also Biopsy, Interventional Ultrasound, Ultrasound Safety, Side Effect and Ultrasound Regulations.

Classification by the Food and Drug Administration of medical devices according to potential risks like e.g. ultrasonic heating. The US FDA 510k document provides guidance in the preparation of a regulatory submission to prevent hazards.