USFDA puts on hold Sun Pharma trials on dermatological drug
The drug major on Tuesday said it had a teleconference call with the US Food and Drug Administration (USFDA) regarding a pulmonary embolism (serious adverse events) occurring at the 12 mg dose in one of the long-term Open Label Extension (OLE) studies.
There have been no thrombotic events reported to date for the 8 mg dose and USFDA has not placed the 8 mg dose on hold, the drugmaker said in a regulatory filing, pic- PTI