BIGMAR, Inc. Receives Suitability Petition Approval From FDA to File ANDA for Dacarbazine.JOHNSTOWN, Ohio--(BUSINESS WIRE)--Dec. 7, 1998--BIGMAR, INC inc - /ink/ increment, i.e. increase by one. Especially used by assembly programmers, as many assembly languages have an "inc" mnemonic. Antonym: dec. . (Nasdaq SmallCap Market:BGMR/Boston Stock Exchange: BGM) announced today that it has received approval of a Suitability Petition by the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. ("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. ") on November 30, 1998, which permits the filing of an 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 ") for Dacarbazine for Injection. Dacarbazine is used in the treatment of metastic malignant melanoma Malignant Melanoma Definition Malignant melanoma is a type of cancer arising from the melanocyte cells of the skin. Melanocytes are cells in the skin that produce a pigment called melanin. and is also indicated for Hodgkin's disease Hodgkin's disease, a type of cancer of the lymphatic system. First identified in 1832 in England by Thomas Hodgkin, it is a type of malignant lymphoma. Incidence peaks in young adults and the elderly. as a secondary-line therapy when used in combination with other effective agents. Approval of the Suitability Petition allows the Company to submit an ANDA for a configuration of Dacarbazine that is not currently approved for marketing in the U.S. The filing is consistent with the Company's broader strategy to seek out unique product configurations in the area of pharmaceutical products focusing on oncology. Peter P. Stoelzle, Executive Vice President of the Company, commented, "This approval provides the Company with an opportunity to offer generic pharmaceutical products with market characteristics unique to both proprietary and generic oncology products. New configurations in pharmaceutical products represent an important step in addressing the specific dosage needs of the patient population who depend on these drug products. We are very pleased that the FDA has given its approval to file the ANDA." BIGMAR, Inc.'s strategy is to supply world markets with a full line of high-quality, affordably priced pharmaceutical products focusing on oncology. With distribution rights to more than 20 generic pharmaceutical products, the Company intends to manufacture, in its state-of-the-art facilities in Switzerland, and market, through pharmaceutical company partners in Europe and the United States, off-patent generic oncology drugs and additional drugs as their patents expire. Forward-looking statements involve known and unknown risks, uncertainties and other factors as detailed in the Company's SEC reports and filings, which may cause the actual results, performance or achievements of the Company, or industry results, to be materially different from any future results, performance or achievements expressed or implied in such forward-looking statements. |
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