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Bigmar Receives Product Approvals From the FDA.


JOHNSTOWN, Ohio--(BUSINESS WIRE)--March 1, 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/Boston Stock Exchange: BGM) today announced that it has received its first 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
") approvals 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 the following products:

-- 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 USP USP - unique sales point , 1g/vial (lyophilized ly·oph·i·lize  
tr.v. ly·oph·i·lized, ly·oph·i·liz·ing, ly·oph·i·liz·es
To freeze-dry (blood plasma or other biological substances).



[lyophil(ic) + -ize.
)

-- 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)

The Methotrexate products are indicated in the treatment of various neoplastic neoplastic /neo·plas·tic/ (ne?o-plas´tik)
1. pertaining to a neoplasm.

2. pertaining to neoplasia.


neoplastic

pertaining to neoplasia or a neoplasm.
 diseases. The Leucovorin products are used to diminish toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosages of folic acid antagonists folic acid antagonists
pl.n.
Modified pterins, such as aminopterin and amethopterin, that interfere with the action of folic acid and produce the symptoms of a folic acid deficiency.
. Leucovorin Calcium for Injection, 500 mg is also indicated in combination with 5-fluorouracil in the palliative treatment of patients with advanced colorectal cancer.

John G. Tramontana, Chairman of the Board and Chief Executive Officer, noted, "With the achievement of this important milestone, Bigmar is well positioned to begin introducing its drug products to the U.S. market. We will now have a truly global marketing presence, as U.S. distribution efforts complement sales activities already realized throughout Europe."

Mr. Tramontana also commented, "Not only does the large number of initial ANDA approvals create significant marketing momentum, the approval of Leucovorin Calcium for Injection USP, 500 mg provides an unique proprietary position, as Bigmar will be the first to offer this configuration in the United States. This product configuration was the subject of an earlier suitability petition approved by FDA. Approval of this product represents an important step in addressing the specific dosage needs of the patient population who depend on them."

Peter Stoelzle, Executive Vice President added, "Bigmar is now one of only a handful of facilities worldwide to utilize barrier isolation technology to manufacture FDA approved parenteral drug products and the only manufacturer to apply this highly automated containment technology to the manufacture of generic drugs. Aseptic processing experts agree that 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. It provides an opportunity to significantly reduce contamination rates during aseptic filling operations."

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.
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 1, 1999
Words:486
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