Xyrem sodium oxybate regulatory update

FDA issued a warning letter noting Jazz's response to the agency's inspection, which identified significant violations in postmarketing reporting and drug safety procedures, lacks sufficient corrective actions. According to the letter, Jazz failed to develop adequate written procedures for the surveillance, receipt, evaluation and reporting of postmarketing adverse drug experiences (ADE) to FDA; and failed to submit the ADE reports, which were serious and unexpected, to the agency within 15 days. Jazz has 15 working days from the receipt of the letter, which was issued on Oct. 11, to notify the agency of specific steps the company has taken to correct the violations.

In early May, Jazz received a Form 483 as a result of the inspection, which discussed the failure to report certain cases of deaths of patients who were prescribed Xyrem sodium oxybate and noted deficiencies in certain of the company's drug safety procedures. The sodium salt form of gamma hydroxybutyrate is marketed in the U.S. to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. ...