Browsing "FDA"
BMY “Consents” to Improper Orange Book Listings
March 7, 2003 The Federal Trade Commission today announced that Bristol-Myers Squibb Company (Bristol) – one of the world’s largest [...]
AAI’s Prosac & Prilosec Patents & Buspar Delisting
July 18, 2001 I – AAI’s Prilosec patents AAI may have something. They apparently have identified that Prilosec is a [...]
BuSpar: Will FDA list BMY new Buspar patent ?
December 4, 2000 Bristol Myers Squibb submitted a new patent, (’365), (which it claims covers BuSpar), to the FDA for [...]
Hatch Waxman Act #1
November 17, 1997 Introduction: Patent protection expired on Glaxo’s Zantac last July, and patents on Cardizam CD expire in 2002. [...]
Hatch Waxman Act #2
Introduction. Infringement by inducement is an important issue in the litigation involving Neurontin, Glaucoma, Prilosec, Buspar, Plavix and ribavarin. Because [...]
Hatch Waxman Act #3
December 30, 2003 Issue: When there is no 30-month stay and generic challenger loses a patent infringement suit how do [...]
Prozac: New rule threatens Barr Labs 180 day exclusivity
August 10, 2000 The commentary provides: “The first court decision finding one of the patents invalid, not infringed, or unenforceable [...]
Schering Plough resolves FDA issues
May 27, 2002 Schering-Plough Corporation (NYSE: SGP) today announced that it has reached an agreement with the U.S. Food and [...]
Schering Plough’s GMP Troubles with the FDA
July 23, 2001 Summary 1- FDA is not likely to seize products because, if there were real quality problems, FDA [...]
Taxol 1: Why did ABI to list 331 in the Orange Book?
April 20, 2000 Background: In April 2000, Ivax won a court order invalidating Bristol Myers Squibb’s (BMY) patent protection on [...]
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