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Biotech / Medical : FDA THRESHOLD: LOWER-RISK BIOTECH INVESTING

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To: opalapril who wrote (52)2/22/2000 8:56:00 AM
From: opalapril  Read Replies (1) of 75
 
TXB

Texas Biotech anticlotting drug approvable


HOUSTON, Feb 22 (Reuters) - Texas Biotechnology Corp. <TXB.A> said Tuesday that it has received an approvable letter from the U.S. Food & Drug Administration for its anticlotting drug Novastan, and that it expects to satisfy requirements for final approval within about 60 days.

Novastan has been developed as an anticoagulant therapy for patients who can no longer receive heparin, a widely used anti-clotting drug.

It is indicated as an anticoagulant for prevention or treatment of thrombosis, or clotting, in patients with heparin-induced thrombocytopenia.

Thrombocytopenia is a life-threatening condition in which there is an abnormally small number of platelets in the blood.

Heparin-induced thrombocytopenia is an adverse reaction to heparin.

Under an August 1997, agreement with SmithKline Beecham Plc <SB.L>, SmithKline has the rights to market and co-develop Novastan in the United States and Canada.

Texas Biotechnology said that it has begun commercial-scale manufacturing of Novastan.

08:14 02-22-00
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