CIS-US Announces Approval of Generic version of Choletec(R) Kit for the Preparation of Technetium Tc-99m Mebrofenin.BEDFORD, Mass. -- CIS-US, Inc. announced today that it has received approval from the U. S. 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. ) Office of Generic Drugs for its Abbreviated New Drug Application abbreviated new drug application Pharmacology An application made in the US by a pharmaceutical company requesting authority to market a 'new' drug for which both its therapeutic indications and formulation were previously approved by the FDA in another similar (ANDA ANDA abbr. abbreviated new drug application ) to manufacture and market a generic 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. Tc-99m Mebrofenin. The company will begin distribution the week of February 4. The Kit for the Preparation of Technetium Tc-99 Mebrofenin is the second agent in the CIS-US product line approved with an indication for hepatobiliary imaging. Jeanne A. Fiore, VP Regulatory Affair and Quality Assurance, stated, "We are pleased to receive approval of our first ANDA filing and the first generic approval for a Kit for the Preparation of Technetium Tc-99 Mebrofenin." Glenn Alto, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of CIS-US stated, "Our approval of the Kit for the Preparation of Technetium Tc-99 Mebrofenin is a gratifying grat·i·fy tr.v. grat·i·fied, grat·i·fy·ing, grat·i·fies 1. To please or satisfy: His achievement gratified his father. See Synonyms at please. 2. start to the expansion of our existing molecular imaging agent product line. Our commitment to the development, production and supply of key products to nuclear medicine practitioners and their patients will be evidenced as we continue to grow our product offerings in the coming months." About CIS-US, Inc. CIS-US, Inc. is a specialty pharmaceutical company headquartered in Bedford, MA with a focus in the manufacture and marketing of molecular imaging agents and in providing contract manufacturing and development services for human parenteral compounds. 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. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. 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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