Tuesday, Apr 1, 1997
South San Francisco, Calif. -- April 1, 1997 --Genentech, Inc., (NYSE: GNE) today announced that it received clearance from the U.S. Food and Drug Administration (FDA) to market Nutropin AQ (somatropin [rDNA origin] injection), the first and only liquid (aqueous) recombinant human 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, Ph.D., president and CEO 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 (powdered) Nutropin® (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.
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