Meridian Receives FDA Approval of Injectable Drug for Pain Management.COLUMBIA, Md.--(BW HealthWire)--Nov. 10, 1999-- Meridian Medical Technologies, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :MTEC) announced today that it has received approval from the U.S. 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 butorphanol tartrate butorphanol tartrate a synthetic opioid with both agonist and antiagonist activities. It is used as an analgesic and antitussive. butorphanol tartrate Stadol, Stadol NS Pharmacologic class: Opioid agonist-antagonist injection, USP USP - unique sales point , a generic injectable drug for pain management. The new product is part of a line of generic injectable drugs developed and manufactured by Meridian and marketed by Bertek Pharmaceuticals, a subsidiary of Mylan Laboratories, a major pharmaceutical company. "Butorphanol tartrate injection, USP is the third product to receive FDA approval in the last several months as part of our licensing and supply agreement with Mylan for a generic injectable drug line, and expands our commercial product base," said James H. Miller, chairman, president and chief executive officer of Meridian. He noted that the agreement capitalizes on Meridian's expertise in drug formulation and sterile manufacturing to develop and produce injectable drugs. Butorphanol tartrate injection is used for pain management, and can be administered intravenously or intramuscularly in·tra·mus·cu·lar adj. Within a muscle: an intramuscular injection. in in three dosage configurations -- 1 mg, 2 mg and 4 mg per vial. The U.S. market for butorphanol tartrate injection totaled $15 million in 1999. Earlier this year, Meridian received FDA approval for generic injectable diltiazem, a drug to treat heart disease with a U.S. market in excess of $53 million in 1998, and for generic acyclovir acyclovir /acy·clo·vir/ (a-si´klo-ver) a synthetic purine nucleoside with selective activity against herpes simplex virus; used as the base or the sodium salt in the treatment of genital and mucocutaneous herpesvirus infections. injection, a drug for herpes viruses Herpes viruses A group of viruses that can cause cold sores, shingles, chicken pox, and congenital abnormalities. The Epstein-Barr virus which causes mononucleosis belongs to this group of viruses. Mentioned in: Infectious Mononucleosis with a U.S. market of more than $28 million in sales during the same period. Bertek Pharmaceuticals plans to introduce the new generic injectable product in the coming months. Mylan Laboratories is a leading pharmaceutical company that develops and markets generic and proprietary prescription products. Meridian Medical Technologies is a worldwide leader in the development of auto-injector drug delivery systems. The company provides technology solutions for medicine in early intervention ear·ly intervention n. Abbr. EI A process of assessment and therapy provided to children, especially those younger than age 6, to facilitate normal cognitive and emotional development and to prevent developmental disability or delay. healthcare and emergency medical technologies and has strong core technologies in non-invasive cardiopulmonary diagnostics. Additional company information is available on the World Wide Web at www.meridianmeds.com. Certain statements contained in this press release that are not historical fact are "forward-looking" statements and involve important risks and uncertainties. Such risk and uncertainties, which are detailed in the company's filings with the Securities and Exchange Commission, could cause the company's results to differ materially from the company's current expectations as expressed in this press release. |
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