Avista Capital Partners' medical imaging business announces exclusivity extension for Cardiolite(R).N. BILLERICA, Mass. -- Avista Capital Partners' recently acquired medical imaging business (MI) reported today that the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has granted pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children. pe·di·at·ric adj. Of or relating to pediatrics. exclusivity for studies conducted on Cardiolite([R]) (Kit for the Preparation of Technetium technetium (tĕknē`shēəm) [Gr. technetos=artificial], artificially produced radioactive chemical element; symbol Tc; at. no. 43; mass no. of most stable isotope 98; m.p. 2,200°C;; b.p. 4,877°C;; sp. gr. 11. Tc99m Sestamibi for Injection), effective January 8, 2008, under Section 505A of the Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C), is a set of laws passed by Congress in 1938 giving authority to the Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. (21 U.S.C. 355a) as amended by the Best Pharmaceuticals for Children Act (BPCA BPCA British Pest Control Association BPCA Battery Park City Authority (New York state) BPCA Business Products Credit Association BPCA Best Pharmaceuticals for Children Act of 2002 (US) ). This grant extends the marketing exclusivity of Cardiolite for an additional six months beyond patent expiration on January 29, 2008. D. Scott Edwards, V.P. of Research and Development at MI, explained, "We believe that this is the first pediatric exclusivity grant for an imaging agent and is the result of extensive clinical trials, involving more than six hundred (600) patients in nine countries over three years." "This substantial investment by our medical imaging business reaffirms our continuing commitment to the Cardiolite brand, our customers and the improvement of patient care," stated Don Kiepert, Chief Executive Officer at MI. Avista Capital Partners acquired the medical imaging business on January 8 of this year. This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 regarding, among other things, statements relating to plans and projections. These statements may be identified by the fact that they use words such as "anticipate," "estimate," "believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. These factors include, among other things, patent positions and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. . For further details and a discussion of these and other risks and uncertainties see the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. |
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