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