Robert's ProAmatine Set For US Approval

Roberts Pharmaceutical's Pro-Amatine (midodrine) is due for approval in the USA shortly; it is set to be the first cardiovascular drug to be reviewed under the Food and Drug Administration's accelerated process, which is already in place for HIV and cancer drugs.

Midodrine is also Robert's first in-house developed compound, and has been designated as an orphan drug for the treatment of orthostatic hypotension. In March, the FDA decided that midodrine was not approvable without further data on the drug's effects on specific symptoms. The agency then reversed this decision and said the drug could be approved on the basis of surrogate endpoints if Roberts conducts Phase IV trials to verify benefit.

Orthostatic hypotension is characterized by a drop in blood pressure upon assuming an upright posture. It has been linked with traumatic injuries in older patients.