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Texas Biotechnology Novastan

Executive Summary

Anti-coagulant argatroban, co-developed with SmithKline Beecham for the treatment of heparin-induced thrombocytopenia, receives "not approvable" letter from FDA on May 8. The Novastan NDA was submitted in July 1997 and the company filed additional data in February, extending the user fee deadline to May 15. Texas Biotechnology will meet with FDA to discuss requirements for further consideration of the drug by FDA
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PS032207

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