FDA gives tentative nod for Zydus Cadila's generic Northera

Patients who have low blood pressure when they stand that is caused by a certain medical condition will soon have a new generic drug available.

The Food and Drug Administration has given a tentative nod to Zydus Cadila’s droxidopa capsules in dosage strengths of 100 mg, 200 mg and 300 mg.

Droxidopa is the generic of Lundbeck’s Northera. It is used to treat symptoms of low blood pressure when standing, caused by a certain medical condition known as neurogenic orthostatic hypotension-nOH. This medication can lessen symptoms of low blood pressure when standing, such as dizziness and lightheadedness.

The drug will be manufactured at the group’s manufacturing facility at SEZ, or the Special Economic Zone, Ahmedabad.