Tag Archive: Food and Drug Administration (FDA)

Jan 01

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL)

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) and denied approval of a fixed-dose nebivolol/valsartan combination tablet for the treatment of hypertension. An FDA advisory panel recommended by a six-to-four vote that the fixed-dose combination medication not be approved for hypertension.

Nov 28

The US Food and Drug Administration (FDA)

The US Food and Drug Administration (FDA) has approved a software program that can noninvasively identify coronary artery blockages, avoiding the need to diagnose the problem via cardiac catheterization. The software is called FFR-CT and calculates fractional flow reserve (FFR).

Sep 28

The US Food and Drug Administration (FDA)

The US Food and Drug Administration (FDA) announced that a safety study of the asthma drug omalizumab suggests that it poses a slightly elevated but serious risk for heart attacks and ministrokes known as transient ischemic attacks.

Aug 23

The US Food and Drug Administration (FDA) has approved of the extended indications for the novel oral anticoagulant apixaban.

The US Food and Drug Administration (FDA) has approved of the extended indications for the novel oral anticoagulant apixaban. The drug is now approved for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) and for the reduction in the risk of recurrent DVT and PE following initial therapy.