Sentences with phrase «drug applications seeking»

Sandoz and other generic drug companies filed Abbreviated New Drug Applications seeking approval to market a generic form of the drug.

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.

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.

A report of the findings, published Oct. 16 in the Journal of Investigative Dermatology, marks efforts to seek approval from the U.S. Food and Drug Administration (FDA) to use the gel application in treatment - resistant skin wounds among diabetics and others, particularly older adults.

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.

The law society's notice of application, filed last year, sought a determination on whether, «by reason of physical or mental illness, other infirmity or addiction to or excessive use of alcohol or drugs,» Nobili is incapable of meeting his obligations as a lawyer.