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Article: Texas Biotechnology Submits Corrected Amendment to the NOVASTAN(R) New Drug Application.
- Article from:
- PR Newswire
- Article date:
- August 23, 1999
CopyrightCOPYRIGHT 1999 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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- Corrected Statistical Reports Continue to Support the Overall Positive Clinical Interpretation of the Efficacy of NOVASTAN(R) (Argatroban) in Heparin
Induced Thrombocytopenia Syndrome
- There Is no Change in the Safety Analysis
HOUSTON, Aug. 23 /PRNewswire/ -- Texas Biotechnology Corporation (Amex: TXB) today announced that, following discussions with the U.S. Food & Drug Administration (FDA), the Company has corrected the amendment to the NOVASTAN New Drug Application (NDA). The corrected amendment replaces the submission on March 19 of this year.
The changes in this amendment involved correcting the coding of patient endpoint data ...