Sentences with phrase «new drug application seeking»
Teva filed an Abbreviated New Drug Application seeking market approval for a generic form of Helsinn's product, and Helsinn responded by filing an infringement action asserting all four patents against Teva.
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Sandoz and other generic drug companies filed Abbreviated New Drug Applications seeking approval to market a generic form of the drug.
Not exact matches
Later this year, they'll seek FDA approval for a new cancer drug and request an additional application for Arcalyst, their first product on the market.
ViaCyte, Inc. announced in July 2014 that it had filed its first Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes, and in August 2014 the IND was accepted, allowing clinical testing to commence.