FDA concludes that Bristol-Myers Squibb did not withdraw its antidepressant Serzone (nefazodone) for safety or effectiveness reasons. The distinction will allow Serzone to be listed in the "Discontinued Drug Product List" in the "Orange Book," permitting generic versions of the drug to remain on the market. The agency decision may assist Bristol in its upcoming product liability lawsuits involving Serzone...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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Sean Keveney is largely unknown in the FDA law space, but likely is familiar and connected to the White House given his work on Trump’s antisemitism taskforce.
