FDA grants Zydus Cadila approval for generic ProAmatine
The Food and Drug Administration has given its stamp of approval to Zydus Cadila for midodrine hydrochloride tablets in dosage strengths of 2.5 mg, 5 mg, and 10 mg.
The product is the generic of Shire’s ProAmatine. It is indicated to treat orthostatic hypotension, or symptoms of low blood pressure when standing.
Zydus Cadila said that its generic would be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad.