Imdur

MEQUON, Wisc.--(BW HealthWire)--Nov. 3, 1998--Kremers Urban announced FDA approval of a generic equivalent of Imdur(R) on Friday October 30 and began shipping commercial quantities of product the same day, making this the first generic equivalent brought to market. Isosorbide Mononitrate Extended-Release Tablets 60 mg are generic extended-release tablets for the prevention of angina pectoris due to coronary artery disease. According to the American Heart Association, an estimated 7.2 million people in the U.S. suffer from this condition.

"At significant cost savings for the patient(1), pharmacists can substitute this generic for the equivalent strength of Imdur(R)," said Mark Aikman, Pharm. D., Kremers Urban's manager. Aikman noted that the product's AB rating to Imdur(R) is extremely positive. "An AB rating to a branded product means that the FDA considers the generic product to be therapeutically equivalent to the brand-name product." As with Imdur(R) or other nitrates, the most common side effect is headache, which can usually be successfully relieved with aspirin or acetaminophen.

Aikman anticipates that the first-to-market and AB rating status plus the quality, safety and significant cost savings of the Kremers Urban generic will assure its success in the over $200 million market. The product will be available in pharmacies across the United States. For complete prescribing information, contact the Company's Drug Safety and Information Department at 1-800-558-5114.

Founded in 1996, Kremers Urban is the generic division of Schwarz Pharma, Inc. and takes its name from the 104 year-old company purchased by Schwarz Pharma in 1986. Schwarz Pharma, Inc. based in Mequon, Wis., is the U.S.-based affiliate of Schwarz Pharma AG, with global headquarters in Monheim, Germany.

(R) Imdur is a registered trademark of Schering Pharmaceuticals, Inc. (1) Imdur(R) AWP $130.46; KU Isosorbide Mononitrate Extended-Release Tablets AWP $116.11

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