BioCentury's websites will be down for upgrades starting at 9 p.m. PDT on Monday, August 26. We expect the downtime to last no more than 6 hours, and we apologize for any inconvenience.

12:00 AM
Oct 11, 2010
 |  BC Week In Review  |  Clinical News  |  Regulatory

Tracleer bosentan regulatory update

FDA issued a warning letter to Actelion after an inspection revealed that the company failed to comply with postmarketing safety reporting requirements for 3 drugs. FDA said the company failed to report serious and unexpected adverse events within the required 15 days after initial receipt of the information for pulmonary arterial hypertension (PAH) drugs Tracleer bosentan...

Read the full 259 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Week In Review

Article Purchase

$35 USD
More Info >