Kremers Urban Introduces First-to-Market Generic Equivalent to Imdur.MEQUON, Wisc.--(BW HealthWire)--Nov. 3, 1998--Kremers Urban announced 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. 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 isosorbide mononitrate (ī´sōsor´-bīd mon´ōnī´trāt), n brand name: ISMO; drug class: antianginal, organic nitrate; action: Extended-Release Tablets 60 mg are generic extended-release tablets for the prevention of angina pectoris due to coronary artery disease coronary artery disease, condition that results when the coronary arteries are narrowed or occluded, most commonly by atherosclerotic deposits of fibrous and fatty tissue. . According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. the American Heart Association American Heart Association (AHA), n.pr a national voluntary health agency that has the goal of increasing public and medical awareness of cardiovascular diseases and stroke, and thereby reducing the number of associated deaths and disabilities. , 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 acetaminophen (əsēt'əmĭn`əfĭn), an analgesic and fever-reducing medicine similar in effect to aspirin. It is an active ingredient in many over-the-counter medicines, including Tylenol and Midol. . 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 AWP Awaiting Parts (military equipment status) AWP Average Wholesale Price AWP Annual Work Plan AWP Associated Writing Programs AWP Amusement with Prizes AWP Any Willing Provider AWP Aerial Work Platform $130.46; KU Isosorbide Mononitrate Extended-Release Tablets AWP $116.11 |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion