Mylan Receives Approval on Oxaprozin Tablets and Spironolactone Tablets.Business Editors/Medical Writers PITTSBURGH--(BUSINESS WIRE)--Aug. 21, 2001 Mylan Laboratories Inc. (NYSE NYSE See: New York Stock Exchange :MYL) announced today that the Food and Drug Administration has approved its Abbreviated New Drug Applications (ANDAs) for Oxaprozin Tablets, 600 mg and Spironolactone spironolactone /spir·o·no·lac·tone/ (spi?rah-no-lak´ton) one of the spirolactones, an aldosterone inhibitor that blocks the aldosterone-dependent exchange of sodium and potassium in the distal tubule, thus increasing excretion of sodium Tablets USP USP - unique sales point , 25 mg, 50 mg and 100 mg. Oxaprozin is the generic equivalent of G.D. Searle and Company's Daypro(R) and is a nonsteroidal anti-inflammatory (NSAID NSAID: see nonsteroidal anti-inflammatory drug. ). Spironolactone is the generic equivalent of Searle Pharmaceuticals, Inc.'s Aldactone(R) indicated for essential hypertension, primary hyperaldosteronism, edematous e·dem·a·tous adj. Marked by edema. conditions for patients and hypokalemia Hypokalemia Definition Hypokalemia is a condition of below normal levels of potassium in the blood serum. Potassium, a necessary electrolyte, facilitates nerve impulse conduction and the contraction of skeletal and smooth muscles, including the heart. . Both products will be manufactured in Mylan's Morgantown, West Virginia facility and shipping will begin in the near future. Mylan Laboratories Inc. is a leading pharmaceutical company that develops, manufactures and markets generic and proprietary prescription pharmaceutical products. The Company markets an extensive line of generic products through three business units, Mylan Pharmaceuticals Inc., Mylan Technologies Inc., and UDL Laboratories, Inc. and branded products through its Bertek Pharmaceuticals Inc. subsidiary. These products are manufactured and sold in a variety of dosage forms including immediate and extended-release oral tablets and capsules and transdermal patches as well as repackaging and marketing multi-source and single-source products in unit dose form. For more information, visit www.mylan.com. |
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