Zydus Cadila gets final nod from USFDA for Droxidopa Capsules

It is indicated for use in people with conditions of the nervous system that can cause low blood pressure

Zydus Cadila has received final approval from the USFDA to market Droxidopa Capsules, 100 mg, 200 mg, and 300 mg (US RLD: Northera Capsules).

Droxidopa works by constricting (narrowing) the blood vessels and increasing blood pressure. It is used to treat low blood pressure that causes severe dizziness or a lightheaded feeling. It is indicated for use in people with conditions of the nervous system that can cause low blood pressure (such as Parkinson’s disease, multiple system atrophy, autonomic failure, and others).

The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad. The group now has 312 approvals and has so far filed over 400 ANDAs since the commencement of the filing process in FY 2003-04.

ANDA approvalDroxidopa CapsulesUSFDAZydus Cadila
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