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FDA clears Genentech's Nutropin AQ for use in Turner Syndrome Patients.


SOUTH SAN FRANCISCO South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif.--(BW HealthWire)--April 1, 1997-- Genentech, Inc., (NYSE NYSE

See: New York Stock Exchange
:GNE) today announced that it received clearance 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.
) to market Nutropin AQ(TM) (somatropin (rDNA origin) injection), the first and only liquid (aqueous) recombinant human growth hormone human growth hormone (HGH): see growth hormone.  product available for the long-term treatment of short stature associated with Turner syndrome.

Turner syndrome affects approximately one in 2,500 female live births. It is a chromosomal disorder that affects females exclusively and invariably results in severe growth failure.

"Today's clearance provides Turner syndrome patients an added convenience with this ready-to-use liquid product," says Arthur D. Levinson Arthur D. Levinson (born March 31, 1950 in Seattle, Washington, United States) is President and Chief Executive Officer of Genentech. He has held these positions since July 1995, and was named chairman of the board of directors in 1999. , Ph.D., president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Genentech. "It also demonstrates Genentech's ongoing commitment to patients and the endocrine community."

Nutropin AQ now has the same indications as Genentech's lyophilized ly·oph·i·lize  
tr.v. ly·oph·i·lized, ly·oph·i·liz·ing, ly·oph·i·liz·es
To freeze-dry (blood plasma or other biological substances).



[lyophil(ic) + -ize.
 (powdered) Nutropin(R) (somatropin (rDNA origin) for injection). Unlike other growth hormone products, Nutropin AQ does not require reconstitution of a freeze-dried powder. Genentech currently markets Nutropin AQ and Nutropin in the United States for children with growth failure due to inadequate growth hormone secretion and for children with growth failure associated with chronic renal insufficiency up to the time of renal transplantation. Nutropin AQ and Nutropin are not intended for use in patients with closed epiphyses (i.e., patients with no remaining growth potential).

Genentech, Inc. is a leading biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals for significant unmet medical needs. The company has headquarters in South San Francisco and is traded on the New York and Pacific stock exchanges under the symbol GNE.

CONTACT: Genentech, Inc.

Betsy Rosenberg, 415/225-7848 (Media)

Paul Laland, 415/225-2742 (Media)

Susan Bentley, 415/225-1034 (Investors)

http://www.gene.com
COPYRIGHT 1997 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1997, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Date:Apr 1, 1997
Words:284
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