Bigmar, Inc. Receives Suitability Petition Approval From FDA to File ANDA for Methotrexate for Injection, 500 Mg.JOHNSTOWN, Ohio--(BUSINESS WIRE)--June 3, 1998--Bigmar, Inc. (Nasdaq SmallCap Market:BGMR/Boston Stock Exchange: BGM) today announced it 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 May 26, 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 Methotrexate methotrexate, drug used in halting the growth of actively proliferating tissues. Introduced in the 1950s, it is used in the treatment of leukemia, psoriasis, and non-Hodgkin's lymphoma. for Injection, 500mg. Methotrexate is used alone or in combination with other anticancer agents in the treatment of breast and other types of cancer. Approval of the Suitability Petition allows the Company to submit an ANDA for a configuration of Methotrexate for Injection 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 oncology pharmaceutical products. John Tramontana, Chairman of the Board 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." The Company has received approvals for three Suitability Petitions from the FDA and has other applications pending approval. The developmental product pipeline for 1998 is on track and full with a steady stream of generic drug generic drug, a drug sold or prescribed under the nonproprietary name of its active ingredients or under a generally descriptive name rather than under a brand or trade name. product submissions. BIGMAR, Inc.'s strategy is to supply world markets with a full line of high-quality, affordably priced generic pharmaceutical products, focusing on oncology. With distribution rights to more than 20 generic oncological 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 oncological drugs and additional oncological 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. CONTACT: Bigmar, Inc. William R. Ash, III, CFO See Chief Financial Officer. (614) 966-5800 Bigmar's Investor Relations Investor relations The process by which the corporation communicates with its investors. Counsel: The Equity Group Inc. Ethan Denkensohn (212) 836-9611 email: edenkensohn@equityny.com |
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