FDANews
FDAnews Drug Daily Bulletin

Mayne Pharma Gets Warning Letter for Failing to Report Adverse Events

March 9, 2005

The FDA has issued a warning letter to New Jersey-based drugmaker Mayne Pharma for failing to submit and investigate numerous adverse drug experience (ADE) reports between 2002 and 2004.

The warning letter, which was released by the FDA March 1, documented 18 instances in which Mayne either didn't submit ADE reports to the agency, submitted them after the required reporting period, or didn't fully investigate the ADE reports. In July 2004, for example, Mayne failed to report two serious adverse events involving its famotidine injection product. According to the FDA, the drug was linked to one case of renal impairment and another incident of multi-organ failure.

The FDA's investigation, which occurred at Mayne's Paramus, N.J., facility between Sept. 13 and Oct. 6, 2004, found similar reporting problems with the company's pamidronate disodium solution, methotrexate sodium injection and cytarabine injection products.

Mayne submitted a response to the violations in November 2004, but the FDA said the response didn't clearly explain whether the company intended to follow up on some of the ADE reports that weren't investigated. The agency ordered Mayne to respond to the letter within 15 days.

To view the letter, go to http://www.fda.gov/foi/warning_letters/g5198d.htm (http://www.fda.gov/foi/warning_letters/g5198d.htm).