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FDA Approves Organon's RAPLON, the First Anesthesia Agent of Its Kind for Outpatient Surgical Procedures; Second Major Drug Approval for Organon in Less Than Three Weeks.


WEST ORANGE, N.J.--(BUSINESS WIRE)--Aug. 18, 1999--

Organon Inc. announced the U.S. Food and Drug Administration's approval today of RAPLON(TM) (rapacuronium bromide) for Injection as an adjunct to general anesthesia to facilitate tracheal intubation intubation /in·tu·ba·tion/ (in?too-ba´shun) the insertion of a tube into a body canal or hollow organ, as into the trachea.

endotracheal intubation
, and to provide skeletal muscle relaxation during surgical procedures. RAPLON was proven in studies to be an effective alternative to succinylcholine succinylcholine /suc·ci·nyl·cho·line/ (suk?si-nil-ko´len) a depolarizing neuromuscular blocking agent used as the chloride salt as an anesthesia adjunct and in convulsive therapy.  with a rapid onset and a short duration of action with the recommended dose.

RAPLON is the first and only nondepolarizing neuromuscular blocking agent nondepolarizing neuromuscular blocking agent
n.
A compound that paralyzes skeletal muscle by inhibiting the release of neurotransmitters at the neuromuscular junction.
 (NMBA) that combines both rapid onset with short duration for tracheal intubations and many short procedures including appendectomy Appendectomy Definition

Appendectomy is the surgical removal of the appendix. The appendix is a worm-shaped hollow pouch attached to the cecum, the beginning of the large intestine.
, tonsillectomy tonsillectomy /ton·sil·lec·to·my/ (ton?si-lek´tah-me) excision of a tonsil.

ton·sil·lec·to·my
n.
Surgical removal of tonsils or a tonsil.
, cystectomy Cystectomy Definition

Cystectomy is a surgical procedure to remove the bladder.
Purpose

Cystectomy is performed to treat cancer of the bladder. Radiation and chemotherapy are also used to treat bladder cancer.
, tubal ligation and Cesarean section.

Outpatient surgical procedures account for approximately 60 percent of all surgeries performed in the U.S., according to estimates.

"Anesthesiologists now have an important new option with fewer side effects such as malignant hyperthermia, masseter muscle In human anatomy, the masseter is one of the muscles of mastication.

It is particularly powerful in herbivores to assist when they are chewing plants. Origin and insertion of the two heads
 rigidity and hyperkalemia Hyperkalemia Definition

The normal concentration of potassium in the serum is in the range of 3.5 to 5.0 mM. Hyperkalemia refers to serum or plasma levels of potassium ions above 5.0 mM.
," said Dennis M. Fisher, MD, Professor of Anesthesiology and Pediatrics at the University of California, San Francisco Coordinates:  . "Clinical studies have shown RAPLON to have a very rapid onset and a short duration of action, which is ideal for both doctors and patients in today's health care environment," said Dr. Fisher.

Hans Vemer, MD, president of Organon, said, "We are thrilled to receive our second major 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.
 drug approval in less than three weeks. The introduction of RAPLON will allow Organon to continue its leadership position in the field of neuromuscular blocking agents," said Dr. Vemer. "We continue to be an innovator in this field, and a reliable supplier offering a full range of products for anesthesiologists."

"RAPLON offers an excellent alternative to both succinylcholine and mivacurium for patients undergoing outpatient (ambulatory) surgery because of its rapid onset and short recovery and favorable side effect profile," said Paul F. White, PhD, MD, professor and holder of the Margaret Milam McDermott Distinguished Chair of Anesthesiology and Pain Management, University of Texas Southwestern Medical Center, Dallas.

The recommended dose of RAPLON is 1.5 mg/kg, which offers a short clinical duration between 15 and 20 minutes. RAPLON will be available in October 1999.

RAPLON adds to Organon's profile of neuromuscular blocking agents for use in a variety of common surgical settings. Among these agents is ZEMURON(R) (rocuronium bromide) Injection, introduced in 1994 as the first rapid-onset, nondepolarizing muscle relaxant for intermediate and long surgical procedures, as well as NORCURON(R) (vecuronium bromide) for Injection and PAVULON(R) (pancuronium bromide) Injection.

Organon Inc. of West Orange, NJ is the U.S. affiliate of N.V. Organon, a renowned international ethical pharmaceutical company. In the U.S., Organon Inc. also markets the anesthesia drugs of Organon Teknika B.V. Organon maintains a strong commitment to healthcare, conducting research in the areas of psychiatry, contraception, fertility, thrombosis, immunology, osteoporosis prevention and treatment of post-menopausal symptoms. Organon Teknika is a worldwide leader in neuromuscular blocking agents and strives to become a global player in anesthesiology through research and alliances.

Organon and Organon Teknika are two of the business units of Akzo Nobel N.V., headquartered in Arnhem, The Netherlands. Akzo Nobel serves customers throughout the world with healthcare products, coatings and chemicals. The Company employs 86,000 people in more than 70 countries, in which consolidated sales for 1998 totaled $13.8 billion. Third quarter results will be announced October 27. In North America alone, Akzo Nobel employs approximately 10,000 people in 125 locations, including its U.S. headquarters in Chicago. Akzo Nobel's North American sales total approximately $3 billion annually. The Company's American Depositary Receipts (ADRs) are traded on 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
 under the symbol AKZOY.
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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:Aug 18, 1999
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