Allergan Inc recently announced the US Food and Drug Administration will require additional information before approving its Botox anti-wrinkle drug as a treatment for upper limb spasticity in adult stroke victims.
The company reported that health regulators have not asked for further clinical studies, a process that may have delayed approval by years.
The FDA will first review the company’s proposed Risk Evaluation and Mitigation Strategy for the medicine before approving it for the movement disorder common to stroke sufferers. The body has also requested additional documentation and analysis of a particular Botox clinical study included in the approval application.
The company also said the federal agency has suggested certain label revisions, including one that may broaden Botox use to upper limb spasticity regardless of underlying cause.
The company hopes to satisfy the conditions in about 60 to 90 days.
Botox is required to carry a strong safety warning for non-cosmetic uses.
[Source: Original press release]