Manhattan Isotope Technology Receives Drug Master File Acknowledgment Letter From FDA
LUBBOCK, Texas, Oct. 9, 2012 /PRNewswire/ -- Positron Corporation, (OTCBB:POSC) a molecular imaging healthcare company, announces that their subsidiary, Manhattan Isotope Technology, LLC, has received an acknowledgment letter and Drug Master File (DMF) number assignment, from the United States Food & Drug Administration (FDA), for its Strontium-82 Drug Substance.
Manhattan Isotope Technology (MIT) has received acknowledgment from the FDA for its Strontium-82 Drug Substance submission and has been assigned DMF #26411. MIT is now permitted to submit Letters of Authorization (LOA) with companies supplying Sr-82/Rb-82 generators. The LOA requests MIT's DMF information be referenced in support of the holders aNDA/NDA applications. This acknowledgment is a requirement which enables the FDA to review information in the DMF with respect to these applications.
For over two decades, Rubidium-82 generators using the parent isotope Strontium-82, have proven to be the radiopharmaceutical of choice in myocardial perfusion imaging with Positron Emission Tomography (PET).
"We are very pleased to have achieved this significant milestone. Assignment of our DMF by the FDA, positions Positron alongside the United States Department of Energy (DOE) and Nordion as DMF holders for Sr-82 Active Pharmaceutical Ingredient (API). MIT is now able to supply drug manufacturers Sr-82 for qualification in their Sr-82/Rb-82 generators. This signifies our Company's official entry into the business of radiopharmaceutical production, the foundation of Positron's end-to-end solution for the cardiac PET industry," stated Jason Kitten, President of MIT.
About Positron: Positron Corporation is a molecular imaging healthcare company vertically integrating all the segments of nuclear cardiology—providing an end-to-end solution for cardiac PET. Through proprietary PET imaging systems, radiopharmaceuticals and radioisotopes solutions, Positron enables healthcare providers to more accurately diagnose disease and improve patient outcomes, while practicing cost effective medicine. Positron's unique products, market position and approach in securing the supply chain are substantial advantages, further accelerating the adoption of cardiac PET and growth of nuclear cardiology. Positron is redefining the industry. More information about Positron is available at www.positron.com.
Forward Looking Statements: Statements in this document contain certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are based on many assumptions and estimates and are not guarantees of future performance. These statements may involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Positron Corporation to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Positron assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Our actual results may differ materially from the results anticipated in these forward-looking statements due to a variety of factors, including, without limitation those set forth as "Risk Factors" in our filings with the Securities and Exchange Commission.
SOURCE Positron Corporation