Roberts' First Pipeline Drug Cleared In USA

The US Food and Drug Administration has approved Roberts Pharmaceutical Corp's ProAmatine (midodrine hydrochloride) for orthostatic hypotension. This is the first of the company's in-house proprietary drugs to be cleared for the US market, according to president and chief executive Robert Vukovich.

ProAmatine was approved for orthostatic hypotension using a surrogate endpoint (standing blood pressure), and becomes the first US-approved drug for this indication. The FDA reviewed the drug under its accelerated approval system as it considered ProAmatine a new drug for a serious or life-threatening condition.