Indevus obtains FDA approvable letter for hypogonadism drug

The letter indicated that the application may be approved if the company is able to adequately respond to certain clinical deficiencies related to the product.

The FDA has expressed a concern about a relatively small number of patients in European post-marketing use who have experienced respiratory symptoms immediately following the intramuscular injection of Nebido 1000mg, 4cc injection volume (versus the 750mg, 3cc injection volume used in the US).

In addition, the FDA believes that four cases in the European post-marketing experience may have an allergic, anaphylactoid component, although the company believes these cases were improperly classified and represent an oil-based phenomenon where the reaction is likely the result of a small amount of the oily solution immediately entering the vascular system from the injection site.

The FDA has requested the company to address these clinical deficiencies by providing detailed safety information from clinical studies to determine the precise incidence of serious post-injection oil-based reactions and allergic reactions.

Glenn Cooper, chairman and CEO of Indevus, said: “We hope to be able to articulate a development plan to address the FDA concerns within the next few months, and for now are maintaining our previous guidance that it may take the company approximately 18 months to re-submit the revised NDA. We will communicate specific guidance on clinical plans and timelines when they are available.”