Mayne cops FDA warning

Mayne Pharma, the pharmaceuticals division of the Mayne group (ASX: MAY) has received a rap over the knuckles from the US FDA for failing to adequately report adverse events resulting from use of its drug products.

Among the incidents cited by the FDA as unreported serious and adverse events were a case of renal impairment and a case of multi-organ failure, both of which developed after patients received an injection of stomach ulcer treatment famotidine. The company also failed to send in follow-up reports in the required time, and in some cases did not follow up serious adverse events at all, said the FDA.

The infractions, uncovered during a routine audit of Mayne Pharma's US head office late last year, have resulted in a warning letter from the FDA. The company said it has been working closely with the FDA since the audit to resolve the issues. Many of the issues had already been identified by Mayne during an internal review of procedures shortly before the audit.

While the warning letter from the FDA advises that it considered Mayne Pharma's "proposed corrective actions to be adequate," a number of Mayne's responses were questioned and the regulatory agency has given the company 15 days to correct deviations and noted violations.

The company said it did not expect the issue to have a material impact on its operating results.

Mayne's share price dropped $0.08 yesterday to close at $4.75.