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BIGMAR Receives FDA Approval for Fluorouracil Injection; Sixth ANDA Approval in 1999.


JOHNSTOWN, Ohio--(BUSINESS WIRE)--March 29, 1999--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 BGMR Bigmar Inc. (stock symbol) ) today announced that it has received 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
") approval from 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.
") for Fluorouracil fluorouracil: see metabolite.  Injection, USP USP - unique sales point  50 mg/mL, its sixth ANDA approval thus far in 1999. Fluorouracil Injection USP is a cost-effective therapy for palliative management of carcinoma of the colon, rectum, breast, stomach and pancreas. This product will be co-marketed and distributed by IVAX IVAX Industrial Vax (Dec Computer)  Corp. in the U.S.

So far this year, Bigmar has received FDA approval for the following products: -0-
-- Methotrexate for Injection USP, 1g/vial (lyophilized)

-- Methotrexate Injection USP, 25 mg/mL, (Preserved)

-- Methotrexate Injection USP, 25 mg/mL, (Preservative-free)

-- Leucovorin Calcium for Injection USP, 200 mg/vial (lyophilized)

-- Leucovorin Calcium for Injection USP, 500 mg/vial (lyophilized)

-- Fluorouracil Injection, USP 50 mg/mL


John G. Tramontana, Chairman and Chief Executive Officer, commented, "Our portfolio of generic oncology products continues to expand with the approval of Fluorouracil Injection. The flow of product approval opportunities is expected to continue, given Bigmar's established pipeline and our unique approach to product development. Bigmar is focused on new product configurations, which may offer economic or therapeutic advantages not yet realized. These developments address the specific dosage needs of the patient population who depend on them. Our recent approval of Leucovorin Calcium for Injection, 500 mg is a direct result of this approach. Bigmar is the only pharmaceutical company approved to offer this configuration in the U.S."

Mr. Tramontana added, "Besides our recent FDA approvals, we are also encouraged by the use of isolator technology at our facility. This technology, which we believe to be the industry benchmark, provides Bigmar with strategic marketing advantages and challenges the drug manufacturing community to consider the benefits of this aseptic processing technique."

Along with the Company's other approved products, Fluorouracil Injection will be produced and distributed from Bigmar's FDA-inspected Barbengo, Switzerland manufacturing facility. This facility utilizes barrier isolation technology to manufacture FDA-approved parenteral parenteral /pa·ren·ter·al/ (pah-ren´ter-al) not through the alimentary canal, but rather by injection through some other route, as subcutaneous, intramuscular, etc.

par·en·ter·al
adj.
1.
 drug products. This technology, where personnel and the outer environment are separated from exposed sterile products and packaging components, can be superior to traditional aseptic aseptic /asep·tic/ (-tik) free from infection or septic material.

a·sep·tic
adj.
Of, relating to, or characterized by asepsis.
 clean room processing by reducing contamination rates during aseptic filling operations. Bigmar is currently the only company to apply this highly automated containment technology to the manufacture of generic drugs.

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 manufactures, in its state-of-the-art facilities in Switzerland, and markets, 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.
COPYRIGHT 1999 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1999, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Mar 29, 1999
Words:503
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